Medical Device Single Audit Program (MDSAP): Fundamentals and Readiness

Gain the knowledge and skills required to successfully host a MDSAP audit within your organization.

Obtain in depth knowledge about this new type of audit and how your organization is best prepared to support the completing of requirements within the allotted time. 
Discover how this program differs from the traditional ISO 13485 through its regulatory audit approach, the grading of nonconformities, and handling of the audit report. This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.

Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries engaged in the MDSAP program.

Who should attend?

  • Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.

Pre-requisites

Delegates will benefit from reviewing the MDSAP Companion Document and ISO 13485:2016 standard before attending this course.

Improve your knowledge of this new program

What will I learn?

On completion of this training, delegates will have the:

Knowledge to: 

  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit program:
    • MDSAP audit processes and their interrelationships
    • MDSAP and organizational regulatory compliance
    • MDSAP reporting and nonconformity grading
  • Explain the differences between MDSAP and other QMS audits
    • MDSAP and auditing in the medical device industry
    • ISO 13485 and ISO 14971
  • Identify MDSAP documentation

 

Skills to:

  • Prepare to host a successful MDSAP audit:
    • MDSAP 7 auditing process requirements
    • Plan audit scopes
    • Analyze data sources required during process audits
    • Analyze control interactions
    • Use correct jurisdictional terminology

How will I benefit?

This course will help you:­­­

  • Improve auditing skills focused on regulatory auditing
  • Improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

What's included?

  • Detailed course notes
  • Lunch
  • Refreshments
  • On completion, you'll be awarded an internationally recognized BSI Training Academy certificate

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >

Course Guide

Download the Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course Guide


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact training@bsigroup.com or call +44 345 086 9000.


Booking a course delivered via Connected Learning Live?

Take advantage of our exclusive offers, only available in July and August 2020*

Book a July or August Connected Learning Live course date and you’re entitled to unlock one of the following benefits:

  • Option 1: Get 50% off a second delegate booking fee
    Offer applicable to public courses delivered via Connected Learning Live in July and August 2020 only. Second delegate must attend the same course date
  • Option 2: Save £500 on a BSI Diploma in Quality Management
    Offer applicable to delegates that have booked a public course delivered via Connected Learning Live in July and August 2020 only

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com

*Terms and conditions: Applies to all public BSI UK training courses, taking place in July and August 2020 via Connected Learning Live only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information. Second delegate must attend the same course date as the first delegate. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. Offer is for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.