The Medical Device Single Audit Program (MDSAP)
Medical device manufacturers can seek out a number of accreditations and programs one major program being The Medical Device Single Audit Program (MDSAP). MDSAP is a singular audit that covers a range of regulatory requirements for multiple jurisdictions. This efficient program allows for one audit to cover the requirements of 5 different medical device markets which include the United States, Australia, Japan, Canada, and Brazil. With a focus on the audit of the Quality Management System (QMS) of the medical device manufacturer, MDSAP can be combined with a CE and ISO 13485 Assessment.
Though MDSAP is a fairly new program, having its 3-year pilot taking place from 2014-2016, its 2017 pilot report data was satisfactory to the MDSAP Regular Authority Council. Regulatory bodies such as the FDA, Health Canada, and more are members of MDSAP while other bodies such as WHO and the European Union observe MDSAP.
Why Should a Medical Device Manufacturer Seek MDSAP Accreditation?
If the Medical Device manufacturer needs an ISO 13485 accreditation and or other accreditation or inspections to ensure they can continue to participate in specific markets such as Australia or Canada, the MDSAP program should be sought out. Even if a manufacturer is not trying to enter a multitude of markets, one MDSAP audit could cover a variety of the regulations and criteria needed for their own business goals and needs.
What are the Benefits of Using MDSAP?
Medical device manufacturers may find multiple benefits when it comes to participating in MDSAP. One of the most prevalent benefits is a “one size fits all” audit approach. Taking the time and resources of one audit to cover multiple audits for a variety of regulatory bodies can save the manufacturer both time and resources. Additionally, the MDSAP program is expected to grow, becoming a reliable outcome for more regulatory bodies to recognize and join as members. Beginning to use the MDSAP can aid in long-term goals for both manufacturer and regulatory bodies.
Is MDSAP Required by Any Regulations or Standards?
MDSAP is currently only required to participate in the Canadian market as Health Canada has only accepted MDSAP certificates since 2019. Other markets covered by MDSAP such as Brazil, Japan, Australia, and the United States are anticipated to make some changes to their requirements, but no such regulations or standards have been announced.
How Can Labtopia Help Medical Device Manufacturers Meet MDSAP Standards?
Labtopia can evaluate your organization’s needs, products, and processes to implement the right-sized quality management system. Working with Labtopia, all services are geared to the identity of your business while also ensuring MDSAP requirements are met. Labtopia offers turn-key quality management system implementations for companies seeking first-time MDSAP accreditation. Additionally, Labtopia offers a-la-cart services for currently accredited companies. Services include:
- Define/Refine Business Processes
- Risk Assessments
- Validation Protocol Design
- Product Quality Reviews
- Supplier Quality Audits
- Third-Party Audit Support