The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit to satisfy the requirements of multiple regulatory authorities — including the FDA (USA), Health Canada, TGA (Australia), ANVISA (Brazil), and MHLW/PMDA (Japan). Our experienced MDSAP auditors ensure that your Quality Management system (QMS) aligns with all applicable regulations while also helping you maintain compliance with ISO 13485.
With Elexes, you don’t just prepare for an audit — you prepare for success across global markets.
Elexes provides tailored support to ensure you meet all MDSAP audit criteria efficiently and confidently. Our services include:
⦿ Gap assessments and readiness reviews
⦿ ISO 13485 QMS audit alignment and remediation
⦿ MDSAP internal audit services and mock MDSAP audits
⦿ Regulatory submission readiness (e.g., FDA, Health Canada)
⦿ Assist during third-party audits and CAPA resolution
⦿ Auditor training for internal staff
Our MDSAP consulting approach is practical, proactive, and scalable, suitable for startups to multinational enterprises.
Choosing the right MDSAP auditors can mean the difference between delayed market entry and seamless global access. With Elexes, you gain:
⦿ Deep regulatory expertise across 5 MDSAP participating countries
⦿ Decade long experience in ISO 13485 and MDSAP frameworks
⦿ Reduced audit risk and faster certification timelines
⦿ Personalized attention with scalable solutions
⦿ Post-audit support and ongoing QMS optimization
Whether you’re new to MDSAP or seeking recertification, our team will guide you every step of the way.
Our MDSAP auditors serve manufacturers, OEMs, and developers across:
⦿ In-vitro diagnostics (IVDs)
⦿ Surgical instruments and implants
⦿ Digital health and SaMD developers
⦿ Wearable and home use devices
⦿ Class I, II, and III medical devices
No matter your device class or target markets, we tailor our approach to meet your unique needs and compliance goals.
Gain clarity with a side-by-side comparison of MDSAP and ISO 13485, and follow a clear path with our step-by-step MDSAP audit preparation flowchart.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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