This webinar will discuss what the new QMSR will require especially in Risk Management under ISO 14971, what a company can do, including a field-tested Device-specific Risk Management and File in contents, structure, format and tools. Major emphasis will be upon risk management in accordance with ISO 14971 (-:2019), primarily patient and user, device and QMS, risk, which currently has only casual reference  in the old 820.30.  The FDA views "people" -user, patient, use environment, including Cybersecurity if applicable, and CGMP compliance overall, risk management, as “essential systematic practice[s]” to ensure that devices are safe and effective. Device  manufacturers will need to enhance risk management procedures for specific devices and in all other areas of their businesses to align with the QMSR.  Design Control (ISO 13485 7.3 Design and Development) will have limited application to Class I devices, but fully involve Class II and III (US classifications) as is currently done in the US.   The QMSR will re-emphasize senior management’s importance in establishing and following a policy of  risk-based quality, with all inspection area revolving around patient / user risk, and a company culture of quality with risk management at its center.  There are other changes which will be discussed during this webinar, but with the primary focus on patient/user risk.   QSIT changes to the new FDA Inspection Manual are thoroughly discussed.  The FDA's new inspection program will not be the old QSIT, but now has CGMP compliance centered on patient / user risk.  This is now the currently used inspection method for the QMSR as of February 02, 2026.

This webinar benefits the following agencies:

• Abbott,  J&J, Integra, Medtronics, etc…
• AQC, RAPS, AAMI, etc.

Why should attend?
The FDA has been working to align its QSR with the worldwide quality systems standard ISO 13485. The Agency has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the old Part 820, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act.  FDA agrees that ISO 13485 represents a more modern QMS approach and “has greater integration of risk management activities and stronger ties to ISO 14971, the risk management standard for medical devices". . . However, one key result of this change will be the need to companies, especially smaller and medium sized device manufacturers to incorporate ISO 14971:2019 more directly into its device specific documentation, e.g., Device Risk Management Files, and ITS QMS, e.g., Quality Manual and SOPs/ Work Instructions. What should the company already have done to assure compliance?  What are the necessary steps to full compliance? What is the content of a Device Risk Management File based on field-tested examples.  QMS improvements? What is now required to maintain full compliance, and meet other expectations of the Agency per existing Guidance Documents, standards, and the FDA's new QMSR Inspection Manual? 

Who should attend?

• Senior management in Devices, Combination Products
• QA / RA
• Medical Device product development teams
• R&D
• Engineering
• Production
• Operations
• Marketing
• Consultants; others tasked with device QA, product development, manufacturing, process / product / data analysis, and regulatory submission responsibilities