MDSAP Fundamentals and Readiness Training
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 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
Cedric Razaname, Veranex
What previous participants said
Contact
Select date
Related courses
ISO 13485 and Quality Management for Medical Devices / Internal Auditing
Training of internal auditors in relation to country specific requirements within the MDSAP program
IRCA Certified ISO 13485:2016 QMS Lead Auditor Training for Medical Devices
In-house Courses
MedTech Academy offers in-house training courses tailored to your specific needs. Courses can be based on our open programme or developed specifically for your organisation. You choose the focus, format and timing – and work with your own cases in a confidential setting. Contact us to discuss the possibilities.
Do You Have a Specific Competency Need?
We continuously develop and update MedTech Academy’s course portfolio to match the current needs of medical device companies. If you are looking for a specific course, or if you are unsure which course is the right fit for you and your organisation, you are always welcome to contact us.
Berit Munkebo
Head of Development
bm@medicoindustrien.dk
Academy News
Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.