US Quality Management System Regulation (QMSR) and other US Regulations for Medical Devices
The course focuses on the newly published Quality Management System Regulation (QMSR) that replaces the Quality System Regulation (QSR) as well as the US-specific regulations using the Medical Device Single Audit Program (MDSAP) as a guidance.
Outcome
The course will start with the newly published Quality Management System Regulation (QMSR) that replaces the Quality System Regulation (QSR) and will continue with the US-specific regulations using the Medical Device Single Audit Program (MDSAP) as a guidance. The focus will be on FDA inspections, illustrated by means of case studies based on results of FDA inspections (Warning Letters).
Course content
The following subjects will be presented and discussed:
- Overview of the new Quality Management System Regulation (QMSR)
- FDA inspections
- MDSAP Country-specific requirements for USA
- Additional U.S. regulations from 21 CFR 1000-1050 and 21 CFR 4
The course will be conducted in English, alternating between lectures, case studies and discussion of participants’ own issues.
Who should attend?
The course has been designed for staff in the medical device industry who need to gain insight into FDA QSR/GMPs and people about to take part in planned FDA inspections. It is an advantage to have some familiarity with the US FDA QMSR/QSR and ISO 13485 before the course.
Trainer
Enzo Passalia
Quality Systems and Regulatory Specialist, DONAWA LIFESCIENCE CONSULTING Srl, Italy
Enzo Passalia specialises in quality systems and regulatory requirements for medical devices. On this course, he guides participants through the FDA’s Quality Management System Regulation (QMSR), US-specific requirements under MDSAP and other relevant US regulations. Drawing on FDA inspection findings and Warning Letters, he translates the regulatory requirements into practical preparation for inspections and day-to-day quality system management.
What previous participants said
Contact
Select date
17-18 december 202622-23 september 2027
17-18 December 2026 - at 09:00 - 15:30
Price ex. VATLatest Registration
15 December 2026
Latest Cancellation
27 November 2026
Bøge Allé 5, 2. th
2970 Hørsholm
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Terms
In-house Courses
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Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.