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The Medpoint Blog

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MDSAP - Are You Ready?

The Medical Device Single Audit Program, better known by its acronym MDSAP, is designed to increase audit efficiency by allowing a single audit to cover the requirements for Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, the U.S. Food and Drug Administration (FDA), and Japan Ordinance on Standards for Manufacturing Control.

Although this program was designed to ease the audit burden on medical device manufacturers, it has also created a growing sense of anxiety across the industry. Because a poor MDSAP audit result can now trigger an audit from each of the governing bodies involved in the program, the pressure for good audit results is now higher than ever.

With deadlines approaching – January 1, 2019 for the Canadian market – the time to prepare is now. And that’s where Medpoint can help. We have MDSAP qualified auditors available to provide a range services to help prepare your team for the audit. Service options include:

Internal Audits – Medpoint auditors are available to come onsite and conduct a thorough internal audit to ensure your systems are ready to withstand the rigors of an MDSAP audit.

Document Review – It’s always good to have an extra set of eyes reviewing documentation. If you have concerns that there may be room for improvement, a Medpoint consultant can review your documentation remotely and partner with you to identify improvement opportunities.

Mock Audits – Make sure your whole team is ready for whatever questions come their way. A mock audit combines the best of training, auditing, and team involvement.

Training – Are you confident your whole team is ready for the audit? If not, an interactive training session may be the perfect way to ensure everyone is prepared.

Whatever your concerns, Medpoint has the professional expertise to help you prepare for MDSAP audits. Find out how you can partner with Medpoint today: or +1 800-200-9292.

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