Management Forum Logo

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"

4-5 July 2024
+ 28-29 November 2024 »

from £1099

Need help?  Enrol or reserve

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

Enrol or reserve

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

Enrol or reserve

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.

More details

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

4-5 July 2024

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 14178

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 30 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

28-29 November 2024

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 14179

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 24 Oct

View basket 

 
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


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

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy