MDSAP QMS Implementation and Audit Preparation
Ensure your medical device QMS meets global standards with MDSAP implementation and audit preparation tailored to your business goals.
Streamline QMS Compliance with MDSAP Certification
The Medical Device Single Audit Program (MDSAP) is a framework that allows medical device and IVD manufacturers to comply with quality management system (QMS) requirements in participating markets with one audit. It was piloted by the International Medical Device Regulators Forum to streamline the audit process for manufacturers who intend to expand their device distribution into other major markets and improve quality outcomes with a consistent approach. An MDSAP certificate can be an efficient and cost-effective QMS compliance strategy for manufacturers who know they want to obtain market authorization in an MDSAP market.
Align MDSAP requirements with your business strategy
MDSAP requirements are based on ISO 13485:2016 plus specific requirements from each participating market, which includes Australia TGA, Brazil ANVISA, Health Canada, Japan MHLW, and US FDA. You don’t need to implement the country-specific requirements of all MDSAP markets, only the market(s) you plan to market your device. For instance, if your QMS includes the requirements from Canada and the US, your MDSAP certificate will only be valid in Canada and the US. Adding MDSAP markets to your certificate will require changes to your QMS and recertification for the new markets. A long-term comprehensive regulatory strategy can help you make the most of your MDSAP implementation resources and audit time.
Understanding the MDSAP audit process
An Auditing Organization (AO), which is similar to an EU Notified Body, will audit your QMS according to a seven-step process and issue a certificate that specifies the market(s) included in your audit scope. Recertification audits occur every three years. However, your AO will perform annual surveillance audits to ensure your QMS remains up to date.
Get ready for your MDSAP audit
MedEnvoy’s experienced and trained QMS auditors are experts in ISO 13485 and MDSAP requirements. We can determine if MDSAP certification supports your long-term market strategy. Then we can prepare you for a successful AO audit.
How we can help:
Design a quality roadmap for your business goals
Our team of regulatory and quality experts can help you assess if MDSAP certification makes sense for your company based on your short- and long-term objectives as well as your current readiness and QMS framework.
Perform gap assessments and readiness audits
We will review your QMS procedures and documentation against MDSAP requirements for your target markets to identify any compliance gaps and areas of improvement. Before your official AO audit, we can ensure your team, documentation, processes, and critical supplier controls will meet auditor expectations.
Internal compliance audits
Maintain compliance with internal audit requirements with help from our experienced quality auditors. We will perform a mock audit of your MDSAP QMS and deliver an audit report of our findings with solutions to address any non-conformities.
Post-audit support
If an AO audit results in non-conformities you need to address, our team can help plan and implement Corrective and Preventive Actions (CAPAs) that satisfy AO criteria.
