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MDSAP Certification for Global Market Access
The Medical Device Single Audit Program (MDSAP) allows manufacturers to meet multiple regulatory requirements through a single audit. Elexes simplifies your MDSAP certification journey by helping you implement and maintain a compliant, inspection-ready Quality Management System (QMS). Whether you're aiming for access to the U.S., Canada, Australia, Brazil, or Japan, we’ll make your path smooth and strategic.
Why MDSAP Certification Matters for Medical Device Companies?
MDSAP streamlines audits and boosts your credibility in key global markets. With regulators like the FDA, Health Canada, and TGA on board, it’s more than a certification, it's a passport to international compliance. For manufacturers expanding globally, MDSAP certification is no longer optional; it’s essential.
At Elexes, we offer:
⦿ Tailored QMS implementation aligned with ISO 13485 and MDSAP
⦿ Gap assessments and internal audits
⦿ Audit readiness and regulator-specific consulting
Our Proven Process for MDSAP Certification Success
We begin with an in-depth gap analysis, comparing your current QMS against MDSAP audit model requirements. From there, we tailor a roadmap that closes compliance gaps and prepares your team for the audit. We provide documentation support, training, and ongoing guidance, all personalized for your product type and target markets.
Elexes has helped Class I, II, and III device manufacturers across diagnostics, SaMD, electromechanical devices, and implantables meet MDSAP standards confidently.
Key Regulatory Bodies Recognizing MDSAP Certification
MDSAP is recognized by five key regulatory authorities. Here’s what it means for your business:
Reduces the need for duplicative inspections and shortens timelines for ANVISA registration.
What’s Included in Our MDSAP Certification Consulting Services
MDSAP Gap Assessment
We evaluate your existing QMS and highlight medical device regulatory compliance gaps with the MDSAP audit model, using ISO 13485:2016 as the core.
Customized QMS Development
Our experts draft or update your procedures, work instructions, and forms aligned to regulatory expectations of each participating authority.
Internal Audit & Mock Audits
We conduct internal audits and simulate real MDSAP inspections to ensure you’re fully prepared and confident.
MDSAP Audit Readiness Training
We provide hands-on training for your quality and regulatory teams to handle MDSAP auditor interviews and document requests.
Audit Support & Representation
From planning to audit closure, we assist with documentation, CAPA responses, and direct interactions with auditing organizations.
Post-Certification Support
Stay compliant after certification with periodic updates, QMS maintenance, and assistance during surveillance audits.
Your Path to MDSAP Certification Starts Here
Let Elexes guide you through every phase with clarity and precision. Below are two resources to help you understand what it takes to become MDSAP compliant.
Ready to Simplify Compliance Across Borders?
Let Elexes help you succeed with MDSAP Certification.
FAQs
Frequently Asked Questions!
MDSAP Certification is a quality system audit recognized by regulators in the US, Canada, Brazil, Australia, and Japan, allowing one audit to meet multiple requirements.
Yes, since January 2019, Health Canada mandates MDSAP certification for all medical device manufacturers selling in Canada.
The full MDSAP process can take 4–8 months, depending on the state of your QMS and audit readiness.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Associated Regulatory Authorities.
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Amazing Feedback About Our Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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