Pre-market Submission, Validation and Cyber-security for Software in Medical Devices
Why Should You Attend:
Software-related documentation in a pre-market submission should be consistent with the intended use of the device and the level of concern and risk. In addition there is the requirement to submit a device hazard analysis for all software devices and types. FDA also reviews information security, networking and wireless technologies during its pre-market review of certain devices with vulnerabilities. Recently the agency provided guidance for mobile medical applications to ensure that they don’t pose risks for the patient. Device and healthcare industry need to take into account all these new and current biomedical software guidelines to provide services and products that ensure patient and consumer safety.
We will explain the current policies, update on upcoming regulations, explore issues and challenges and discuss how manufacturing, health IT and mobile industry will be affected. Examples and cases will be presented for different roles. We will also explore relevant device software regulations, news and standards in US and globally. Since the computers and software applications grew rapidly the last years, the regulatory environment becomes complex and multidimensional for many stakeholders. Industry and vendors need to get policy updates regularly to save time and cost in their processes.
Areas Covered in the Webinar:
- Overview And Timeline Of Biomedical Software Regulations
- Pre-market Submissions For Software Contained In Medical Devices
- Software Validation For Medical Devices
- Quality System Regulations CGMP, Applied To Devices
- Cyber-security For Networked Medical Devices
- Information Security For Certain Types Of Devices
- Medical Device Data System Rule And Mobile Medical Applications
- Future Of Software Regulations And Standards In The Biomedical Field Globally
