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.

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

By the end of this course 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 sucessful 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

Practical information

This two-day training course includes lunch and drinks. The training and the materials will be provided in English. For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or call 0031-(0)20-3460780.