Who it’s for
Who should attend
Quality managers and management representatives preparing for MDSAP certification, internal auditors, regulatory affairs staff, process owners who will be audited, and senior management of manufacturers supplying two or more MDSAP markets.
Curriculum
Course modules
- Origin and purpose of MDSAP; the Regulatory Authority Council and participating regulators
- How each of the five regulators uses an MDSAP audit report
- The MDSAP Audit Model and its process-based structure
- The four primary processes: Management; Measurement, Analysis and Improvement; Design and Development; Production and Service Controls
- The three supporting processes: Purchasing; Device Marketing Authorization and Facility Registration; Medical Device Adverse Events and Advisory Notices Reporting
- Process linkages and the required audit sequence
- Country-specific tasks embedded in the audit model
- Audit types: initial certification Stage 1 and Stage 2, surveillance, recertification, special audits
- Nonconformity grading, the escalation rules and outcomes
- Audit time determination
- Auditing Organizations and auditor competence requirements
- Preparing for and hosting an MDSAP audit
Outcomes
What you’ll be able to do
- Follow the MDSAP Audit Model through a full audit
- Grade nonconformities correctly
- Prepare an organization for MDSAP certification
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 “Medical Device Single Audit Program”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.