Presented by
Management Forum
Medical Device Single Audit Programme (MDSAP) Training Course
A Comprehensive and Practical Introduction
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
★★★★★ "I was hoping to gain a better understanding of the MDSAP requirements, how they are implemented with... more"
25-26 November 2026 »
from £1299
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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- Medical Device Single Audit Programme (MDSAP)
Overview
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
The MDSAP audit is based on BS EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes - with the applicable regulatory requirements of the participating jurisdictions – Australia, Brazil, Canada, Japan and the USA – included as areas of focus. Audits conducted in accordance with the MDSAP follow a closely prescribed process of defined tasks. An MDSAP audit uses a process approach, based on a foundation of risk management, to select samples of procedures and records to examine. The audit focuses on how risks are identified and addressed.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
This course is part of our range of Medical Devices training courses
Recommended Reading
It is recommended that delegates have access to the MDSAP Audit Guide and ISO 13485:2016 standard prior to attending the course.
Benefits in Attending
- Gain a comprehensive overview of MDSAP
- Enhance your understanding of the MDSAP audit approach
- Recognize how MDSAP supports the regulations in the participating jurisdictions
- Understand the MDSAP processes and their interrelationships
- Learn how to implement the MDSAP audit model
Who Should Attend
- Quality Management System (QMS) specialists
- Regulatory Compliance specialists
- Internal Auditors
- Regulatory and Quality professionals
Popular with...
This course has proven particularly popular among our customers in these roles:
- Regulatory Affairs Manager
- Regulatory Affairs Officer
- Student
This course will cover:
Introduction and welcome
Overview of MDSAP
- Background to MDSAP
- Benefits for regulators and manufacturers
- Participating jurisdictions
- Auditing organizations
- Interaction with EU regulations for medical devices
MDSAP audit approach
- MDSAP process sequence
- MDSAP audit planning
- Grading of nonconformities
- Post audit activities
- MDSAP documents
Management process
- Audit tasks
- QMS planning
- Policy and objectives
- Management review
Device marketing authorisation and facilty registration
- Audit tasks
- Marketing authorization
- Facility registration
- Change notification
Syndicate exercise - Management process
- Feedback and discussion
Measurement, analysis and improvement
- Audit tasks
- Data sources
- Investigations
- Nonconforming product
- Post-production information
Adverse events and advisory notice reporting
- Methodologies
- Introduction to threat modeling
- Relation to safety risk management
Syndicate exercise - Measurement, analysis and improvement
- Feedback and discussion
Q & A
Introduction and recap of Day one
Design and development
- Audit tasks
- Regulatory requirements for design and development
- Design and development planning
- Risk management
- Design and development processes
- Design and development transfer
Syndicate exercise - Design and development
- Feedback and discussion
Production and service controls
- Audit tasks
- Planning of product realization
- Production control
- Contamination control
- Infrastructure
- Process validation
- Sterile devices
- Monitoring and measuring equipment
- Documents and records
- Handling, storage and delivery
Syndicate exercise - Product and service controls process
- Feedback and discussion
Purchasing
- Audit tasks
- Planning of purchasing
- Purchasing controls
- Supplier selection
- Verification of purchased product
Syndicate exercise - Purchasing
- Feedback and discussion
Wrap up and Q & A
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
Please contact us for pricing if you are interested in booking 5 or more delegates
25-26 November 2026
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 16575
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 21 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Reviews of IPI's Medical Device Single Audit Programme (MDSAP) training course
I was hoping to gain a better understanding of the MDSAP requirements, how they are implemented within an organisation, and how they compare with ISO 13485 and other regulatory requirements. The webinar met my expectations and gave me a solid overview of the MDSAP framework and its practical implementation. Stuart was knowledgeable, engaging, and explained the topics clearly. He used practical examples that made the requirements easier to understand and encouraged interaction throughout the session. The overall experience was excellent.
Jun 25 2026
Jills Mathew 
Quality & Regulatory Associate, CamDiab
Jun 25 2026
I was hoping to achieve a global understanding of the logic followed in MDSAP audits and a more precise understanding of the tasks that concern me (marketing authorizations). I believe I now understand this part quite well. the speaker seemed to be very knowledgeable in this area.
Mehdi BENAMEUR 
Regulatory Affairs & Registrations, Laboratoires Théa
Jun 25 2026
Great training. I am now much more informed and confident. Will keep my eye open for other trainings like this.
Rhys Higginson
Regulatory Affairs Specialist, Spectrum Medical
Jul 10 2025
Objective: to get a better understanding of MDSAP requirements was well met by training. Very well put together and delivered. The presenters came across very knowledgeable and experienced, and valuable insight was shared through group discussions. I really liked the structure and pace of the course, and it was suited to my needs.
Sukhjit Sidhu
Quality Assurance and Compliance Specialist, Sterimedix Ltd
Mar 27 2023
Excellent
Amy Wright 
Quality Manager Nox Medical LLC, Nox Medical
United Kingdom
- CamDiab
- Clinical Computing UK Limited
- Mimetrik Solutions Ltd
- Spectrum Medical Inc
- Sterimedix
- Sterimedix Ltd
Korea, Republic Of
- Dongguk univ.
- Dongguk University
Poland
- LiNA Medical Polska Sp. z o.o.
- LiNA Medical Sp. z o.o.
France
- Laboratoires Théa
Iceland
- Nox Medical
Italy
- Spectrum Medical S.r.l.
Run Medical Device Single Audit Programme (MDSAP) Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
