Medical Device Single Audit Programme (MDSAP) Fundamentals and Readiness

This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMSprocesses are consistent with the requirements of the MDSAP audit mode for the jurisdictions where yourproducts are marketed.

 

(This course is GST inclusive) 


Who should attend?

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

What will I learn?

  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit program
  • Explain the differences between MDSAPand other QMS audits
  • Prepare to host a successful MDSAP audit.

How will I benefit?

  • Improve auditing skills focused on regulatory auditing
  • Improve competence for MDSAP internal auditors and the supportneeded to host a MDSAP audit
  • Assess your own audit models andsuggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected AuditingOrganization
  • Receive a globally recognized certificate

Next Steps

  • Lead Auditor: ISO 13485:2016 - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
  • Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.