Julie O.
Total Contributions 346
Dec 6, 2017John Rohe, How do you see CAPA citations proving that? I don't think they prove...
Dec 6, 2017Gabe, how is it Ginger?...
Dec 5, 2017Richard, no argument there. Perhaps I should have put IF in all caps ("IF you...
Dec 5, 2017Roger, yes, that's the cycle I've seen. Whether this can be considered a business model,...
Dec 1, 2017To key off of Shelby's comment, the innovation it will theoretically kill are digital products...
Nov 30, 2017Potentially a reasonable business strategy, if you can quantify the rewards to be realized with...
Nov 30, 2017It will be interesting to look back in 5-10 years to see what exactly each...
Nov 29, 2017Given the consistency over time, it seems likely that this is a viable business model...
Nov 27, 2017I would expect the product manager, not a member of the engineering team, to be...
Nov 27, 2017Arthur, your comment about it being a default position of FDA caught my eye. I...
Nov 26, 2017Mark, the federal government's procurement processes are a separate topic. Pretty much anything is going...
Nov 26, 2017Mark, it's unfortunate that cybersecurity has an adversarial role in some companies, but it does...
Nov 22, 2017What is the process by which cybersecurity could kill device innovation? I'm stumped....
Nov 21, 2017How would it? ...
Nov 16, 2017Executive management is accountable to the company’s shareholders. Without being able to crunch the numbers,...
Nov 16, 2017What would be really interesting to know is whether the company's manufacture of these defibrillators...
Nov 16, 2017"Specifically, the complaint alleged that, while Philips initiated corrective and preventive action in response to...
Nov 4, 2017All things in moderation......
Nov 4, 2017Melanie, what do you see as the source of this pressure? And its target?...
Oct 31, 2017" holder of sound in a particular format' is what I call the "contraption," for...
Oct 30, 2017Jan van der hoek, the "true cost" of a product is not shown on a...
Oct 30, 2017Does anyone know which of these innovations were developed by startups versus established device companies?...
Oct 30, 2017That's no better, IMO. It would better if you made no claim at all as...
Oct 29, 2017Whether or not it is a medical device that is subject to regulatory oversight is...
Oct 23, 2017In the past year, companies have been hiring lots of contract writers to up date...
Oct 19, 2017Ben, there hasn't been any explanation the times I've heard someone make this statement. I'm...
Oct 19, 2017Potential side effects of neurostimulation:• Allergic reaction to medications during implant surgery• Infection at implant...
Oct 17, 2017No implants, please....
Oct 16, 2017Dennis, I was thinking along the lines of a relatively small number of patients enrolled...
Oct 15, 2017I guess it depends on the goals of the investors you are pitching to. If...
Oct 14, 2017You may be at the wrong stage as well. If you don't yet know enough...
Oct 12, 2017If it isn't going to make it possible to affect the progression of the condition,...
Oct 12, 2017I agree, it might be more of a wrong question than a broad one. If...
Oct 9, 2017Sina, there is no reason disposable devices are inherently lower in quality than a reusable...
Oct 9, 2017Whatever the class of device, transitioning from pharma to devices can be a challenge. They...
Oct 6, 2017Maybe marketing, indeed. I'm thinking maybe FDA is touting this and some other relatively modest...
Oct 3, 2017And it was highlighted in a session at the MDIC annual meeting today, lol. ...
Oct 1, 2017Joe, thanks. It's pretty much the only LI forum I've found useful, so I'm happy...
Oct 1, 2017Roger, there was also a special panel presentation on the topic at the IMDRF Stakeholders...
Sep 26, 2017Interesting perspective on this guidance. Trying to figure out why FDA does...anything...is a perpetual source...
Sep 26, 2017"For those of you who have worked on similar medical device press releases, can you...
Sep 26, 2017"Shuren acknowledges that many companies launch first in Europe and then in the US, and...
Jun 28, 2017There is seldom any justification for a company filing a drug-device combination as a drug....
Jun 28, 2017Everyone who has been in the industry for any period of time has read this...
Jun 27, 2017John Hudak, that's certainly a valid hypothesis. One problem I've always had with it is...
Jun 21, 2017Thanks, Richard. I'm something of a data junkie, always wanting to know exactly what the...
Jun 20, 2017If you are talking about the article MDDI published in June 2016, it didn't report...
Jun 19, 2017Thanks, Ginger. I've been thinking that if these devices pose low enough risk to support...
Jun 18, 2017I don't see how a certification program would be expected to support innovation. I would...
Jun 16, 2017I've pondered this and have not been able to make sense of it. All I...
Jun 12, 2017You might want to check Elsmar Cove for discussions of this topic....
Jun 12, 2017G M, how would you imagine Rich might get paid for this info in the...
Jun 12, 2017I think that horse left the barn a long time ago. The concern at this...
Jun 12, 2017I recommend you contact the manufacturer. The question to ask is not whether it is...
Jun 9, 2017I don't think the medical profession is any more likely to back a consumer product...
Jun 9, 2017IMO, the US regulatory status of these products is currently in limbo:In July 2016, FDA...
Jun 8, 2017I'm not sure what you mean when you say that it isn't a "classified medical...
Jun 8, 2017In what types of pharma/device studies do the patients complete the study forms?...
Jun 6, 2017" increased patient engagement in leveraging patient's familiar mobile devices vs traditional paper and pen...
Jun 2, 2017From Arjang: "The key is to mitigate your risk by controlling the CM, which takes...
Jun 1, 2017Caitlin, I agree many people would like to know, but I'm not sure anyone really...
Jun 1, 2017Mark, another good analogy, but I will pick at "...will need..." I think the problem...
Jun 1, 2017Aaron, why are risks higher in Canada?...
May 31, 2017I don't fully understand what you are proposing, but any appearance of the term "own"...
May 31, 2017Tom, I like your analogies! But in terms of conveying odds to a medical device...
May 31, 2017Christine, I'm not sure there is a right group, but if you think of one...
May 31, 2017Aaron, that sounds like a great startup. May I ask where they got the money...
May 30, 2017Danish, we all wish you the best of luck with your venture. To bottom line...
May 30, 2017It is also useful to keep in mind that "actual costs" are what someone spent,...
May 30, 2017Aaron, I agree it is doable and your points are very much on target. In...
May 29, 2017G M, to be fair, he didn’t ask anyone to identify costs, but resources for...
May 29, 2017Danish, that information will be useful to you only to the extent that what other...
May 29, 2017The uncertainty associated with the outcome of routine heart surgery conducted by an experienced and...
May 29, 2017On the contrary, I could argue that odds are pretty much the only thing that...
May 28, 2017Andrew, therein lies the question of selection criteria. The only information provided is that "We...
May 28, 2017A 510(k) filing costs $4,690 or, if you can secure small business status, $2,345, plus...
May 28, 2017Testing is design verification, and therefore part of the cost of designing a medical device,...
May 24, 2017I wonder what criteria they used to select these 72 out of the 7,000 in...
May 23, 2017It is a business risk because it costs the company money to repair under warranty,...
May 21, 2017Brian, that's a good point. If this testing is not routinely required, it may be...
May 16, 2017James, as long as humans are involved, there will be no refuge from politics, nor...
May 14, 2017The costs associated by regulatory oversight have to be paid by someone. It seems the...
May 13, 2017A lot of things are in flux in the EU these days, but, as far...
May 13, 2017Marcelo, I'm pleased to have your comments on this topic.I think that is both a...
May 13, 2017Roger, it seems to me that tort reform is over, and now the government gets...
May 13, 2017John, we didn't forget that, because it was never true:"...as Free and Independent States, they...
May 13, 2017Pete, Obamacare didn't create an expectation of free healthcare, it responded to it. Governments are...
May 9, 2017Alexander, government involvement is a proximate cause, not a root cause....
May 9, 2017Bob, what would you rather see that 17% be spent on?...
May 9, 2017Fear of personal injury lawsuits has little impact on device reporting these days, largely because...
May 9, 2017Roger, "fixing problems" is not the next phase of the discussion. That discussion took place...
May 9, 2017Roger, I know of nothing in Part 820 that "requires" human factors testing....
May 9, 2017Users are not required to report "when a device caused or contributed to injury." They...
May 5, 2017I don't know if it is what broke healthcare, but I can't say I'm a...
May 5, 2017Ah, so it was really the unions that broke healthcare and the government was just...
May 3, 2017But they might respond to someone from Path. Specificity has its place, but don't discount...
May 3, 2017Any decent survey tool (and Survey Monkey is one) can be set up to accept...
May 1, 2017Love this article. I would be so bold as to suggest a small edit:"Valid data...
Apr 25, 2017"Today’s feeding techniques involve a lot of hope - you put food down the tube...
Apr 25, 2017It looks like the PI for the clinical trial is very well qualified. I see...
Apr 19, 2017I agree that medical device design house customers are not likely to have much interest...
Apr 19, 2017I don't think MDSAP includes registration, only QS audit?...
Apr 19, 2017Hany, how many people do you think have registered a similar medical device in all...
Apr 19, 2017RA should not be making marketing decisions, only informing them....
Apr 18, 2017Oliver, I think that probably depends on your perspective. From the patient's perspective, yes, a...
Apr 16, 2017William, I agree, my mind boggles at the thought of outsourcing R&D whole cloth, but...
Apr 16, 2017I'm pretty sure diabetes patients think the holy grail for treating diabetes is one that...
Apr 15, 2017Christine, it appears that guidance on sample sizes applies only to human factors validation testing....
Apr 14, 2017My standard is that every sample size must be supported by a sample size justification....
Apr 11, 2017Actually, ALL 510(k)s require clinical evidence. Only 10-15% of those that are cleared include data...
Apr 10, 2017Frank, I'm using the definition in FDA's draft guidance. I've been under the impression that...
Apr 10, 2017Please note that is a paper on regulatory approval of medical devices written by someone...
Apr 8, 2017But then you are talking way beyond LDTs, which by FDA definition aren't intended for...
Apr 8, 2017I stand by my advice. The movie does a great job of presenting the many...
Apr 8, 2017Which of the three options for getting the Executive Order revoked is most realistic depends...
Apr 5, 2017I suggest (seriously) that you start by watching Erin Brockvich and paying close attention to...
Apr 3, 2017Please. I've already had enough of people trying to persuade us that health insurance as...
Apr 3, 2017Now I think you are really overreaching. There is a big difference between what people...
Apr 2, 2017Thanks, Greg. It will be interesting to see where this goes....
Apr 1, 2017"The program curriculum addresses all aspects of the medical product development process..."From what point to...
Apr 1, 2017I wouldn't go that deep into regulatory issues. There are already regulatory certificate and degree...
Apr 1, 2017Shyam Giri, medical DEVICE design and development, yes. ...
Mar 31, 2017Very interesting. Has Dr. Marik's work been published in a medical journal?...
Mar 31, 2017I think Ryan was telling those who want government out of Healthcare that this isn't...
Mar 31, 2017"Students who will complete this program will be ready to work in settings such as...
Mar 29, 2017It makes sense to me that Republicans would want not want to replace or repeal...
Mar 25, 2017Is there any information available on the methodology used to collect these data? Many such...
Mar 14, 2017And please can we have people who understand research methodology design these studies too......
Mar 7, 2017To cut to the chase:"As it stands now, the AHCA reflects recent rhetoric, and would...
Mar 6, 2017Tom Herr, can you explain why you would caution against it? What is the risk...
Mar 6, 2017So, Trump would seem to be one of those people who thinks that what they...
Mar 4, 2017If it's the same clients that used to handle it themselves now wanting you to...
Mar 4, 2017Yuhan Zhu, why would medical device software be inherently simpler than "pure software"? I'm not...
Mar 4, 2017It's been interesting to read the responses to these questions. To me Question 0 is...
Mar 4, 2017Sarah, in the US a breast pump is a device "used to express milk from...
Feb 28, 2017I would expect companies to continue to rely on ISO 13485 certification to meet most...
Feb 26, 2017This doesn't make sense to me:"Existing certificates to the MDD or IVDD can be issued...
Feb 26, 2017Different regulatory jurisdiction use different definitions to determine what is and is not a medical...
Feb 23, 2017G M, I decided he meant than an "NRTL sign" wasn't needed in order to...
Feb 22, 2017Matteo, then perhaps readers have misunderstood your meaning here:"The path to approval is both time-consuming...
Feb 22, 2017"the average of 77% of a medical device budget required for regulatory compliance in the...
Feb 22, 2017What is a medical grade computer?...
Feb 21, 2017Richard, in what sense is the user a patient?...
Feb 21, 2017Amin, unfortunately it isn't possible to search FDA's premarket databases for SaMDs or MMAs, but...
Feb 21, 2017Doug, ethical integrity and scientific integrity are separate issues, and the one does not affect...
Feb 20, 2017Yes, this is all true. Medical products are not something to get involved in if...
Feb 20, 2017I don't think you are in a position to enforce anything through the NB or...
Feb 20, 2017As for precedent, there may be some, but because of the lack of transparency in...
Feb 20, 2017"The aesthetics market is largely not reimbursed by insurers, which is generally considered a significant...
Feb 19, 2017The validity of any data is determined by the study design and data analysis, not...
Feb 18, 2017Nice summary. I've found that the most common tripping point is a too-narrow understanding of...
Feb 18, 2017It probably also means that the manufacturer should pay for postage to mail the printed...
Feb 16, 2017So who handled the "necessary" patent application? A patent attorney? Some other type of attorney?...
Feb 14, 2017Joseph, simply put, if the NBs haven't required companies to do something, many companies are...
Feb 13, 2017"May you live in interesting times."Tort reform - "Sometimes, no matter how hard you beat...
Feb 11, 2017My experience is the same as yours. I am used to seeing them listed in...
Feb 2, 2017Lakshman, this web page has a link where you can sign up to receive emails...
Feb 1, 2017Rick, like I said, I don't think anyone has any compelling data to support or...
Jan 30, 2017Sam, I don't think anyone really has any compelling data to either support or reject...
Jan 30, 2017Rich, I think the important question is not how the EO might impact FDA's rule-making,...
Jan 15, 2017TK, what would you recommend in terms of fixing Sarbanes-Oxley?...
Jan 12, 2017Paula, can you provide links to the sources from which you have taken your figures?...
Jan 9, 2017It's my understanding that AdvaMed is a global organization:"AdvaMed advocates on a global basis...""...leads the...
Jan 9, 2017In what sense has the US been the world leader? That is, how is "leadership"...
Jan 5, 2017"Is it realistic in this early stage to question whether the MDR is raising the...
Jan 5, 2017Roderick, I agree with your general observation, but in this case I think the Triangle...
Dec 15, 2016Paul, then I'm inclined to think that is simply another example of expectations that were...
Dec 15, 2016It may also be helpful to consider what types of manufacturing processes your devices will...
Dec 15, 2016You're very welcome!...
Dec 15, 2016Andrew, you are correct that there will be a number of regulations that apply to...
Dec 15, 2016Catharina, raising the regulatory bar in any industry almost always results in some "cleansing," as...
Dec 14, 2016If the device is 510(k) exempt, there is nothing to file, but you have to...
Dec 12, 2016Chaz, yes, it is based on a lot of people repeating the same thing. As...
Dec 12, 2016Paul, what is "it" is that BD is doing wrong, and why is that the...
Dec 12, 2016Steven, I agree the new Rule ends the debate on how e-cigs as currently marketed...
Dec 12, 2016Rich, can you provide the section of ISO 14971 that disallows the use of labeling...
Dec 11, 2016Harold, I would describe nicotine delivery products as relatively low risk. Health risks posed by...
Dec 11, 2016Jean, yes, as of this past August, FDA has been regulating e-cigarettes as tobacco products....
Dec 11, 2016Stephen, are there data available to support these claims?...
Dec 9, 2016I don't think e-cigarettes meet any part of the definition of a medical device under...
Dec 7, 2016Keith, I think this update provides is a pretty good description of software classification under...
Nov 29, 2016Your reference to existing products makes me wonder what type of startup you are talking...
Nov 29, 2016I don't know anything about the funding of new contract manufacturers, but I would guess...
Nov 29, 2016Within the US medical device environment, when people talk about a medical device startup, they...
Nov 22, 2016FDA regulation of homeopathic products:http://www.fda.gov/drugs/newsevents/ucm430539.htm...
Nov 22, 2016Guy, Is there a problem with establishing a (not sure what you mean by "real")...
Nov 21, 2016Gary, I keep asking medical device companies the same question....
Nov 21, 2016"Homeopathy" is one of those words that seems to be used as often or more...
Nov 21, 2016Yeah, like people who seek homeopathic are going to believe the federal government. It is...
Nov 21, 2016The placebo effect has been confirmed scientifically. No reason the placebo shouldn't be homeopathy. If...
Nov 21, 2016How it looks to investors depends on how you present it to them. Their reaction...
Nov 21, 2016I was under the impression that that last slide got tossed sometime ago already.What does...
Nov 21, 2016You are talking process validation, not design validation, right?...
Nov 15, 2016Linda, this is consistent with my impression that Trump has focused on pharma, but that...
Nov 15, 2016Paul, from where you sit, I can see no dramatic impact, but from a regulatory...
Nov 13, 2016Is it safe to say that Califf's tenure as FDA Commissioner will be a short...
Nov 11, 2016Erdem Tarhan I recommend you check out the IMDRF and get your Turkish IEEE to...
Nov 11, 2016Erdem, Mohamed, you both appear to be working for multinationals. Does your company make any...
Nov 10, 2016I haven't seen anything to suggest Trump has given the device industry much thought, but...
Nov 10, 2016Jason, hopefully someone with a deep knowledge of ACA/reimbursement/insurance will eventually weigh in on Joe's...
Nov 10, 2016Caitlin, IMO, the only efforts that really contribute to sustainability are those that help build...
Nov 9, 2016Jason Cotham, I think you may be overestimating the insurance industry's dedication to keeping its...
Nov 9, 2016Jason, if you were responding to my comment, it wasn't a comment on who does...
Nov 9, 2016Blake, I share your perspective that Obamacare wasn't any kind of great leap...forward or backward,...
Nov 8, 2016Scott, the goals I referred to are those of the agencies and NGOs, eg:http://www.un.org/sustainabledevelopment/sustainable-development-goals/But ...
Nov 8, 2016Caitlin, I think Option 1 is an example of an approach that, if it worked,...
Nov 8, 2016Caitlin, no I don't think we have a miscommunication. The link I posted wasn't intended...
Nov 8, 2016Oops, got the options mixed up. Option 3 is the one that strikes me as...
Nov 7, 2016Caitlin, how would you assess your three options in terms of your goal of sustainability?...
Nov 7, 2016Abraham, that's the sustainability issue Caitlin raised. It's ultimately up to each country to assess...
Nov 6, 2016I will assume you are referring to listing the device with FDA.Yes, I think you...
Nov 6, 2016So I would say that someone at Medtronic had their eye on the big picture...
Nov 6, 2016So it all comes back to your idea of "developing." Certainly many smaller medical device...
Nov 6, 2016As for the cost of the devices, that's not really an issue, I don't think....
Nov 6, 2016https://procurement.usaid.gov/search/node/medicalI didn't open the announcements to see if they might shed some light, but I...
Nov 5, 2016"Is the cost of the sales and distribution in developing nations prohibitively expensive even for...
Nov 4, 2016Try searching some the large online job boards for the type of job you are...
Nov 1, 2016Have you purchased the standard yet?...
Oct 31, 2016Ginger Cantor Of course I agree, althou...
Oct 31, 2016Are you looking for guidance on how to set up a QMS that is certifiable?...
Oct 29, 2016Paul, whatever you call them, there is a world of difference between modifying/improving something that...
Oct 29, 2016Paul, I think you probably have it backwards. Beancounter CEOs are not new. If they...
Oct 27, 2016Michel, Marcelo, I think the point of confusion is "This looks and sounds like pharmacovigilance...
Oct 27, 2016Stephen Griffin Could you clarify exac...
Oct 27, 2016Seriously, how would we know? The patent office grants over 300,000 patents per year. How...
Oct 27, 2016I'm also aware that developers sometimes have their patents infringed, but they lack the resources...
Oct 26, 2016Adrian, it's not the designation, but the qualifications that read like they were lifted verbatim...
Oct 26, 2016I'm inclined to agree that, if a legitimate effort has been made to license the...
Oct 26, 2016Moi?...
Oct 26, 2016Joe Atkins, RN,MBA,CNN,CHT, how did FDA...
Oct 25, 2016Michel, when I was young, it was very common to see a plaque hanging in...
Oct 25, 2016Mark, I just have to go on the record and say that there is no...
Oct 25, 2016We can only hope that it will hurt the investment that hurts medtech....
Oct 25, 2016I was always taught that the philosophy in such actions is "Sue everybody, and let...
Oct 24, 2016As for the definition in the MDR, my cynical side says that this requirement was...
Oct 24, 2016This term is used in a number of different contexts, so that anyone using the...
Oct 23, 2016Rob, thanks for the two examples. I always look first at the management team, and...
Oct 23, 2016Mark Plait, excellent point. Always read the fine print. Some CROs (and other service providers)...
Oct 23, 2016The question of CRO or no CRO is more usefully addressed as CRO or...what? DIY?...
Oct 22, 2016And once you analyze them, then what?...
Oct 21, 2016Paul, I'm not sure they can. You aren't talking about innovation, but invention. I agree,...
Oct 21, 2016John, I have no comment on the tax, except that it occurred to me it...
Oct 20, 2016Terrance, realistically, the similarities between FDA and any other third party will vary widely depending...
Oct 20, 2016Alex, I'm experiencing some confusion that may be due to use of terminology and perhaps...
Oct 20, 2016Joe, I was surprised too, given that device trials have been such a hot topic...
Oct 20, 2016John Eckberg If you buy into the equally unsubstantiated, ...
Oct 20, 2016Paul, thanks. Zero methodology = zero credibility, so I will ignore. ...
Oct 18, 2016Samantha, it is the medication that FDA would use for classification, because the type of...
Oct 18, 2016Jean, I'm not sure exactly what process they are proposing to follow. Michelle's article includes...
Oct 18, 2016John, link?...
Oct 17, 2016As I understand it, FDA isn't considering reclassifying wound dressings AS drugs, but reclassifying dressings...
Oct 17, 2016For capitalism and democracy to co-exist, they must first be able to exist. I don't...
Oct 17, 2016Stacy, the truest thing I know about politics is that you can't elect change....
Oct 17, 2016The problem is that, once you stray from the basic definitions, everyone has their own...
Oct 17, 2016Paul, when people talk about things being broken, often those things are working just fine,...
Oct 14, 2016Willi, thanks for the additional info. I'm in no position to disagree with your basic...
Oct 14, 2016Jon, I always say that the process IS the product, by which I mean that...
Oct 14, 2016David, that rule applies only to commodities....
Oct 11, 2016Joe, okay, but then the original answer, pick another project, doesn't make any sense. It's...
Oct 11, 2016Willi, do you have a source for the 1% probability?...
Oct 10, 2016Big enough for what?...
Oct 10, 2016Marc, no, I don't think we are in disagreement, just focusing on different aspects....
Oct 9, 2016William, I would be interested to hear more about your perspective on root causes.Is it...
Oct 8, 2016"There is still the assumption that...it is the NHS, and not the patient, that is...
Oct 8, 2016Ken, thanks for the additional info. I also anticipate significant growth in POC devices.Marc, true,...
Oct 6, 2016Ken, what are your thoughts on the shift to developing minilabs?...
Oct 5, 2016"Devices are from Mars; pharma is from Venus."...
Oct 5, 2016What is it they say about assumptions?...
Oct 5, 2016FDA released a draft guidance on the use of EHR in clinical trials a couple...
Oct 5, 2016A couple of points of clarification…When I said “past Statistics 101,” I did mean “past,”...
Oct 5, 2016Given the nature of your product, I’m not clear on why you want to highlight...
Oct 4, 2016Has someone has successfully hacked into corporate financial records industrywide and nobody told me? Otherwise,...
Oct 3, 2016Talal, if you ask an audience of regulatory professionals when start-ups come to them for...
Oct 3, 2016Yes....
Oct 3, 2016A lot of people join professional organizations primarily to expand their credentials...to list them on...
Oct 3, 2016Thanks, Joanna and Joe, but I think it's me. I wasn't able to bring it...
Oct 2, 2016Nice looking flowchart, but I can't get it to expand to a legible size. Is...
Oct 2, 2016Rodney, when you refer to the prevalent SW culture, are you talking about "real programmers,"...
Sep 30, 2016Talal, perspective is everything. :) As a physician, you bring quite a lot to the...
Sep 30, 2016Are you talking about a description of an investigation of the problem that led to...
Sep 30, 2016Herman, I was thinking about how this issue really isn't limited to software device start-ups....
Sep 29, 2016Talal, V&V is part of the design process. It's your device; you are designing it....
Sep 29, 2016Paul, then I guess I'm not sure what you mean by the "middle."...
Sep 28, 2016Thanks, Maurizio. I will be interested to see how/when/if the MDR plays out....
Sep 28, 2016http://www.raps.org/rac/ will cover regulatory. ISO is not a regulatory agency, so its standards are not...
Sep 28, 2016Brad, Laura's problem (shared by untold thousands) is that it is difficult to get past...
Sep 28, 2016Oh..."countries," not "companies."...
Sep 28, 2016I'm inclined to think most of the views here (and elsewhere) are myopic in terms...
Sep 28, 2016Lynn:http://www.investopedia.com/terms/i/industrylifecycle.aspIt seems clear to me that the traditional US device industry is well into the...
Sep 28, 2016Regarding the short-term, that's business, with a focus limited largely to the next quarter and...
Sep 28, 2016Are you equating PMA devices with devices that treat completely unmet medical needs, 510(k) devices...
Sep 27, 2016I think it may be useful to distinguish the outlook for the US medical device...
Sep 27, 2016My perspective as a life-long unaffiliated voter with a good bit more than average experience...
Sep 23, 2016Maurizio, can you confirm my understanding the much touted "public access" to EUDAMED is not...
Sep 18, 2016No. The EU does not practice much in the way of transparency. It's my understanding...
Sep 7, 2016Omar, I hear you, but that's the way it was. Whether it is still that...
Aug 29, 2016Alessandro, that depends on what they mean by 'CE marked."...
Aug 29, 2016Devastating news about Ryley. I trust that anyone and everyone in this group who has...
Aug 28, 2016I can only hope that others here will do you the kindness of explaining the...
Aug 23, 2016Stephen Glassic, it's an old movlie plot already, e.g:http://www.imdb.com/title/tt0092208/ ...
Aug 23, 2016Anil Bhalani, I don't understand your perspective. It seems to me that this person would...
Aug 21, 2016Michael, I'm inclined to think that, if you follow the trail of breadcrumbs back a...
Aug 21, 2016David, I would guess that that the threats now after everyone has already done it...
Aug 17, 2016I still need to ask FDA about rejections. Will let you know......
Aug 17, 2016Michael, FDA numbers submissions in the order in which they were received. DEN160003 is posted...
Aug 14, 2016Thanks, Joe. I hope others find it informative/interesting/useful. I did it mostly to feed my...
Aug 14, 2016So, one correction to these data so far. The number of De novos submitted in...
Aug 11, 2016Markie E., thanks for t...
Aug 9, 2016Markie, how does ACA promote innovation?How has it brought "us" (who, exactly?) to focus on...
Aug 9, 2016Scott, and who exactly is this consumer who is going to drive the costs of...
Aug 9, 2016TK, the junk insurance was as predictable an outcome of ACA as the mortgage defaults...
Aug 7, 2016Jean, I find myself once again in danger of hijacking a thread, so I for...
Aug 2, 2016IMO, regulatory compliance *is* Quality. How would you satisfy the one without satisfying the other?...
Jul 31, 2016Given what seems to be coming, I think it would be very helpful if FDA's...
Jul 30, 2016Thanks to everyone who has commented thus far. I fielded this question to a number...
Jul 30, 2016Ana, you might also want to post this question at Elsmar Cove:http://www.elsmar.com/Forums/index.phpIt has a forum...
Jul 27, 2016Is there some way to know whether a device was "made in China" if the...
Jul 26, 2016Like medical devices made anywhere, they are as good as the buyer assures them to...
Jul 26, 2016CEB, the same principle applies, I think. It depends on how well the American manufacturer...
Jul 24, 2016Divya, just put your cursor over Stacy's name next to her comment. A Message link...
Jul 21, 2016Here is the current list of 28 Member States. An EUAR can be located in...
Jul 21, 2016To expand on John and Tom's comments, I don't work with design firms much, but...
Jul 18, 2016Are you talking about some type of regulatory category?...
Jul 14, 2016No...start with the customer and work FORWARD! That's where you start with design controls, and...
Jul 11, 2016I attended an early conference on AI and neural networks, somewhere in Southern California, circa...
Jul 10, 2016Carolyn, just because you're being sarcastic doesn't mean they aren't out to get you. :)...
Jul 5, 2016Miklos, that sounds about right. I'm surrounded by large CROs, and their regulatory specialists have...
Jul 5, 2016For those that haven't read the article, and are just responding to the title of...
Jul 5, 2016There are a lot of activities that get bundled together under QARA. Some of them...
Jul 3, 2016Miklos, fascinating comment. What kind of regulatory professionals do you know that are mostly not...
Jul 3, 2016Nebrido, "A conclusion is where you stopped thinking." It is an opinion which has a...
Jul 3, 2016When I transitioned from medical writing to regulatory years ago, I hoped I'd never have...
Jun 26, 2016It is interesting to hear all the different perspectives. My perspective is always how to...
Jun 24, 2016Karen, I would also expect the UK to continue to accept CE marked product. ...
Jun 24, 2016It's been awhile since I reviewed CA/NB 101 and I haven't had a chance to...
Jun 24, 2016Patrick, I was wondering if the UK had had strong opinions/influence on some of the...
Jun 21, 2016Hard to say from a set of slides, but it seems like transparency will remain...
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