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
Somashekara Koushik Ayalasomayajula
SME – Quality & Regulatory Affairs, Digital Health, ISOLA Life Sciences Consultants.
Somashekara Koushik Ayalasomayajula is a quality and regulatory affairs specialist with more than 12 years of experience across medical devices, IVDs and digital health. On this course, he guides participants through the structure and audit approach of MDSAP and the links between its audit processes and the jurisdiction-specific requirements of the participating markets. He also helps organisations assess their readiness, prepare relevant evidence, understand nonconformity grading and identify gaps in their ISO 13485-based quality management system.
What previous participants said
Contact
Select date
14-15 juni 20272-3 december 2027
14-15 June 2027 - at 09:00 - 17:00
Price ex. VATLatest Registration
13 June 2027
Latest Cancellation
23 May 2027
Bøge Allé 5, 2. th
2970 Hørsholm
View Program
Terms
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
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