MDSAP Fundamentals and Readiness Training

BSI will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your organization to know you are prepared and ready to host audit

Objective and outcome
This course is broken down into a combination of knowledge and skills. You will increase your knowledge of the guidelines for conducting MDSAP Regulatory audits and the skills needed within your organization to know you are prepared and ready to host the audit.
 
Content
On completion, successful delegates should gain the displayed knowledge and skills:
 
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 for successfully hosting a MDSAP audit:
  • MDSAP 7 auditing process requirements
  • Plan audit scopes
  • Analyze data sources required during process audits
  • Analyze control interactions
  • Use correct jurisdictional terminology

Who should attend
This course is designed for anyone from the medical device industry with responsibility for one or more elements of an organization’s quality management system, including staff and top management in regulatory compliance, QA/QC, and internal auditing.
 
Trainer
Peter Reijntjes – Tutor BSI
 

Kontakt

Morten Petersen
Uddannelseskonsulent
49184703