Medical Device Regulation (MDR) General Overview (EU) 2017/745 

Medical Device Single Audit Program

Online Medical Device Single Audit Program (MDSAP) Overview 

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Completion time                                    

8 hours                                                     

 

Support period                                     

90 days                                                        

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No additional fees

No membership or assessment fees 

We have partnered with Comply Guru, an expert leader in online training to make our MDSAP course available as an eLearning course.

Course Content

Your course is fully online. 

 

This interactive online training course on the Medical Device Single Audit Program (MDSAP) has been created for Medical Device Clients selling into multiple jurisdictions and specifically into Canada.  

 

MDSAP is intended to allow MDSAP recognised Auditing Organisations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulator authorities participating in the program.

This is not just a simple read and understand MDSAP course, this is a practical 'how to' guide course which you can actually use immediately to get you through the MDSAP audit process.

After this online MDSAP course, you will understand: 

▪    What the MDSAP is

▪    How the MDSAP works and the requirements 

▪    How the MDSAP fit with other certifications

▪    How an MDSAP audit differs

Assessment


You’ll be assessed through one online multiple choice exam. In order to successfully complete the course, you will need to obtain a grade of 70% or higher. Successful completion will entitle you to receive a certificate of completion.

Entry Requirements 

Working knowledge of medical device quality management systems (QMS) is recommended.

Submit your interest →

Make an enquiry below and one of our team will send you more information about the course and answer any questions you have. 

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Address

Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk

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