Who it’s for
Who should attend
Quality managers, quality engineers, internal auditors and management representatives at manufacturers supplying the US market, regulatory affairs staff, US agents, and anyone transitioning an existing QSR-based system.
Curriculum
Course modules
- From QSR to QMSR: what changed on 2 February 2026 and why
- Incorporation by reference of ISO 13485:2016 and ISO 9000:2015 Clause 3 terminology
- Subpart A: scope, definitions, and 820.10 requirements for a quality management system
- Subpart B, supplemental requirements: control of records (820.35) including complaints, servicing and UDI; device labelling and packaging controls (820.45)
- Where FDA requirements sit on top of ISO 13485 and where the two conflict
- Combination products: 21 CFR Part 4 conforming edits
- FDA inspections after QMSR: retirement of QSIT and the Compliance Program 7382.850 inspection approach
- ISO 13485 certification versus FDA inspection authority
- Transition and gap assessment for an existing QSR-based quality system
Outcomes
What you’ll be able to do
- Map an existing quality system to the QMSR structure
- Identify the FDA-specific requirements that ISO 13485 does not cover
- Prepare for an FDA inspection under the current inspection programme
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “USA Quality Management System Regulation”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.