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.
★★★★★ "Excellent"
6-7 July 2023
+ 30 November-1 December 2023
from £1099
- 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 Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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
The Medical Device Single Audit Programme (MDSAP) 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
6-7 Jul 2023
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.
30 Nov-1 Dec 2023
Nancy Consterdine
Ivdeology
Nancy Consterdine is a joint director in her 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.
She has over 30 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex II list products. Also identifying regulatory strategies around global submissions (EU, FDA, Health Canada, TGA, Russia, Latin America and China). She has a special interest in labelling and UDI requirements.
Book Medical Device Single Audit Programme (MDSAP) Live online training
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
6-7 July 2023
Live online
09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Course code 12748
- GBP 1,299
- EUR 1,869
- USD 2,129
- 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
30 November-1 December 2023
Live online
09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
04:30-12:30 New York (UTC-05)
Course code 12749
- GBP 1,099 1,299
- EUR 1,616 1,896
- USD 1,817 2,129
Until 26 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.
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
Poland
- LiNA Medical Polska Sp. z o.o.
- LiNA Medical Sp. z o.o.
Iceland
- Nox Medical
