This webinar will discuss what the new QMSR will require and where the FDA will focus in its compliance inspections.  A key element is the incorporation of ISO 13485 into the new 820 by reference.  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:" risk management as an “essential systematic practice” to ensure that devices are safe and effective. The Final Rule will enhance some parts of ISO 13485.  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. The concept and definition of the make-up and role of "the customer", a term familiar to ISO but not the old QSR.  There are other changes which will be discussed during this webinar, with the primary focus on patient/user risk.   QSIT changes to the new Manual are thoroughly discussed.  The FDA's new inspection program will not be QSIT, and would not be a substitute for an ISO 13485 certification procedure if one is required, nor would those who hold a Notified Body ISO 13485 certificate be exempt from FDA inspection.  This is now the currently used inspection method for the QMST since 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. Part of the reason for harmonizing its regulations with ISO 13485 is to reduce the regulatory burden for device makers who sell products in both the US and in EU / Asia, by eliminating redundancies involved. The Agency has determined that the requirements in ISO 13485 are, when taken in totality, substantially like the requirements of the current 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". QSIT has also been basically eliminated, with the new or revised areas of key inspection interest outlined in the new Inspection Manual 7382.850, with its 7 major + 4 supplemental areas of focus. 
What should the company already have done to assure compliance?  
What are the necessary steps to full compliance?  
To maintain full compliance, and meet other expectations of the Agency as per existing Guidance Documents?  

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,  regulatory submission responsibilities