Presented by
Management Forum
Medical Device Single Audit Programme (MDSAP) In-house Training
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.
★★★★★ "Excellent"
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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 GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
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
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
Stuart Angell
Ivdeology
Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
Reviews of IPI's Medical Device Single Audit Programme (MDSAP) training course
Excellent
Mar 27 2023
Amy Wright 
Quality Manager Nox Medical LLC, Nox Medical
Korea, Republic Of
- Dongguk univ.
- Dongguk University
Poland
- LiNA Medical Polska Sp. z o.o.
- LiNA Medical Sp. z o.o.
Iceland
- Nox Medical
Run Medical Device Single Audit Programme (MDSAP) Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- 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 in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
