MDSAP: Medical Device Single Audit Program

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is a program that allows a single audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory jurisdictions. This audit is conducted by an MDSAP-recognized Auditing Organization (AO) and covers the requirements of the participating regulatory authorities, including the US FDA, Health Canada, Brazil's ANVISA, Australia's TGA, and Japan's MHLW/PMDA.

Our team assists you in preparing for MDSAP audits, ensuring that your quality management system is aligned with the requirements of all participating regions, simplifying your global compliance efforts.

We specialize in helping medical device manufacturers navigate the MDSAP process, ensuring that your devices meet the stringent regulatory requirements of these key global markets. Our expert team provides comprehensive support, from preparation through to successful audit completion, ensuring that your company is ready for a successful MDSAP audit.

Key Benefits of MDSAP:

  • Streamlined Auditing Process: MDSAP allows for a single audit to satisfy the regulatory requirements of multiple countries, saving time and resources while ensuring compliance across key markets.
  • Global Market Access: By complying with MDSAP, your medical device can enter some of the most significant global markets with a single, recognized audit, reducing complexity and increasing competitiveness.
  • Reduced Audit Frequency: Instead of undergoing separate audits, manufacturers only need to complete one audit for all participating MDSAP markets.
  • Improved Regulatory Compliance: We ensure that your quality management system (QMS) is aligned with the broad regulatory requirements covered by MDSAP.

Our MDSAP Services Include:

  • MDSAP Readiness Assessment: We conduct a thorough review of your QMS to assess its compliance and identify gaps.
  • QMS Implementation & Optimization: We assist in ensuring your QMS meets MDSAP standards, from document control to risk management.
  • Audit Preparation & Support: We help organize documentation, train your team, and conduct mock audits.
  • Post-Audit Support: Our team assists in implementing corrective actions (CAPA) and ensuring ongoing compliance.
  • Training & Awareness: We provide customized training sessions to prepare your team for MDSAP audits and long-term compliance.

Why Choose Us for MDSAP Compliance?

  • Expert Guidance: Our team has extensive experience in MDSAP and understands regulatory frameworks across participating countries.
  • Cost and Time Efficiency: By reducing the need for multiple audits, we save you time and money while ensuring compliance.
  • Comprehensive Support: We offer end-to-end assistance from readiness assessments to post-audit corrective actions.

Let us simplify the MDSAP process for you, ensuring that your medical devices meet global regulatory requirements with a single, efficient audit. With our expertise and guidance, you can accelerate market entry and focus on delivering safe, high-quality medical devices to your customers.