An in-depth guide to the Medical Device Single Audit Programme

Medical Device Single Audit Programme (MDSAP) is a global approach devised to audit and monitor the manufacturing of medical devices, with the objective of improving their safety and effectiveness.

It is an international initiative led by Regulatory Authorities to implement a programme where a single audit of a medical device is accepted by multiple regulators to address QMS/GMP requirements.

With the stated objective to: develop, manage and oversee a single audit programme to allow a single regulatory audit to satisfy the needs of multiple jurisdictions. The MDSAP will confirm and provide evidence of compliance with the ISO 13485 standard and the medical device regulations in Canada, Brazil, Japan, Australia and the US.

Although the EU is currently just an observer, the success of the programme suggests it may be extended to other countries and Canada will actually enforce the MDSAP as mandatory in 2019.

In order to help manufacturers understand the MDSAP and how their businesses can harness it, Maetrics, a leading international consulting firm focusing on providing life science companies with deep quality, compliance and regulatory solutions, has released a free guide and business analysis.

The practical whitepaper is divided in two main sections:

• an informative section, which focuses on an easy to understand analysis of the MDSAP including a stakeholder map, benefits from each jurisdiction and a review of the MDSAP structure
• a business analysis section, which provides a SWOT analysis and information to make strategic decisions

Peter Rose, Managing Director Europe at Maetrics, said: “The MDSAP is an exciting opportunity for medical device manufacturers and the industry to become more transparent and coordinated in its regulatory requirements, while at the same time providing the public with safer, better and more closely monitored products."

Click here to download the whitepaper