In 3 Steps to an Offer for MDSAP Certification
- You send your request in 1 minute.
- We briefly clarify scope and timing based on the data you provide.
- You receive reliable quotes including audit planning.
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MDSAP certification with auditors who know the FDA, Health Canada, TGA, ANVISA, and MHLW/PMDA rulebook.
DQS is a recognized MDSAP Auditing Organization. One audit, conducted by a single experienced team, covers the regulatory requirements of the five participating jurisdictions, reducing audit burden and accelerating your access to the world's most demanding medical-device markets.
Recognized AO under MDSAP
Audits accepted by all participating regulators.
One audit, five markets
Cuts audit days, costs, and disruption.
Cross-regulation expertise
Auditors fluent in FDA, HC, TGA, ANVISA, MHLW/PMDA.
Aligned with FDA QMSR
Supports compliance with the FDA Quality Management System Regulation, effective since February 2026.
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Five regulatory doors — one structured audit
MDSAP transforms how medical-device manufacturers manage global regulatory audits. Instead of preparing repeatedly for separate inspections, you align your QMS once against ISO 13485 plus the country-specific requirements of all five MDSAP participating regulators.
MDSAP audits are performed using the internationally harmonized MDSAP Audit Approach, which evaluates organizational processes against ISO 13485 requirements together with applicable regulatory requirements from participating jurisdictions.
The result is a more efficient route to multi-market access and significantly less audit fatigue.
Typical Effects of MDSAP Certification in practice
The value of certification extends beyond external proof of conformity. Many organizations use recurring audits and assessment processes as a framework for continuous improvement, operational transparency, and stronger cross-functional alignment. In practice, companies often report effects such as:
- Substantially fewer total audit days across multiple regulatory markets.
- Less business disruption from routine inspections, e.g. for FDA-regulated sites.
- Stronger, harmonized QMS evidence usable across global regulatory filings.
- Greater predictability in audit planning, scope, and reporting structure.
- Smoother access to FDA, Health Canada, TGA, ANVISA, and MHLW/PMDA markets.
Start MDSAP Certification with DQS Now
Save time and internal effort with a clearly structured certification process. Request your personal quote for your MDSAP certification now.
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Who Will Benefit from MDSAP Certification
MDSAP is designed for medical-device manufacturers operating across regulated markets:
- Manufacturers selling devices in the United States, Canada, Australia, Brazil, or Japan.
- Companies already certified to ISO 13485 looking to streamline multi-market regulatory audits.
- Health Canada-regulated manufacturers: for whom MDSAP is mandatory.
- FDA-regulated firms preparing for the QMSR transition that took effect in February 2026.
- Global organizations seeking to consolidate audit programs across multiple jurisdictions.
DQS is Your Trusted Partner for MDSAP Certification
Our Audit Approach
MDSAP Certification process
A clear process means fewer questions and faster results. These are the stages of your MDSAP certification with DQS — transparent from start to finish.
Information
The process begins with information meetings to discuss your audit objectives, the certification process, and the scope of your management system. This first step helps clarify which sites, products, jurisdictions, and regulatory requirements are relevant for your MDSAP certification.
Offer, application, and contract
Based on your scope and certification needs, DQS prepares a detailed offer specifying the scope of services and the planned time schedule in a transparent manner. Once the offer, application, and contract are agreed, the certification project can formally begin.
System analysis (Stage 1 audit)
DQS conducts a readiness review of your quality management system to determine whether it is prepared for certification according to ISO 13485 and the applicable MDSAP requirements. This includes an assessment of relevant system documentation and other key QMS evidence.
Quality management system assessment (Stage 2 initial certification audit)
The main audit includes a comprehensive on-site assessment of your management system, conducted in accordance with the MDSAP Audit Approach. The objective is to evaluate the adequacy and efficiency of the QMS and to establish conformity with the requirements of the applicable standards and regulations. Audit results and findings are presented during the closing meeting.
Audit summary and recommendation
Following the audit, DQS prepares a written report summarizing the audit results and any required action plans. The report also includes the auditor’s certification recommendation, based on the findings from the assessment.
Issuance of certificate
DQS MED assesses the audit results independently and decides on the issuance of the certificate. If the certification decision is positive, your organization receives the MDSAP certificate within the defined certification scope.
First and second surveillance audit
Following the initial certification audit, surveillance audits are conducted in years two and three of the certification cycle. These audits review essential elements of the management system on site and confirm continued conformity with the applicable MDSAP and ISO 13485 requirements.
Re-certification
Before your current certificate expires, DQS conducts a comprehensive re-certification audit to thoroughly assess your quality management system. Upon successful completion, you receive a new certificate valid for another three years, ensuring continued compliance and starting a new three-year cycle.
Is your company ready for MDSAP Certification?
- ISO 13485-based QMS implemented and operating across all relevant sites.
- Defined jurisdictional scope: which of the five MDSAP markets apply to your devices.
- Country-specific regulatory requirements mapped into procedures and records.
- Internal audits and management review cycles completed and demonstrating effective implementation of ISO 13485 and applicable regulatory requirements.
- Design, production, and post-market processes documented with evidence available.
Once your organization meets these requirements, you are ready to contact DQS to begin your MDSAP certification.
You Already Have a Certified Management System?
MDSAP can be efficiently combined with EU MDR and ISO 13485 audits. A bundled approach reduces duplication for organizations operating across multiple medical-device regulatory frameworks at once.
Frequently Asked Questions about MDSAP Certification
How Long Does MDSAP Certification Take?
From inquiry to MDSAP certificate, most manufacturers complete the process in 6 to 12 months, depending on QMS maturity, site count, and jurisdictional scope. Learn more in our MDSAP Knowledge Center.
How Long is an MDSAP Certificate valid?
MDSAP certificates are valid for three years, with mandatory annual surveillance audits. Recertification at the end of the cycle confirms continued conformity. Learn more in our MDSAP Knowledge Center.
What does an MDSAP Certification Cost?
Cost depends on the number and complexity of sites, device categories, and jurisdictions in scope, plus required country-specific tasks. Request a quote to receive a tailored offer covering the full three-year audit cycle.
What is the effort involved in achieving MDSAP Certification for my company?
Most effort goes into mapping country-specific regulatory requirements onto your existing ISO 13485 QMS and preparing process owners for an audit model that integrates five regulators. Learn more in our MDSAP Knowledge Center.