The most important word of the MDSAP acronym is “Single,” because the program is offering an “all-in-one” audit to accommodate multiple legislations. The industry would be well-advised to treat this as a positive change as the collaboration and support amongst the stakeholders will be the most effective and efficient way to implement the Medical Device Single Audit Program.

Our MDSAP whitepaper provides guidance for the industry to prepare for MDSAP and emphasizes the business advantages that can be drawn out of the program.

  • an informative section, which focuses on an easy-to-understand analysis of the MDSAP including a stakeholder map, benefits from each jurisdiction, as well as a review of the MDSAP structure
  • a business analysis section, which provides the details needed to make the best strategic decisions based on internal and external factors.

Maetrics has longstanding experience applying new and complex standards consistently and efficiently while developing compliance strategies critical to your company’s success. Our third party support for MDR, IVDR, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across the whole review and implementation process.

Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies.