Combined audits for medical device certification
Streamline certification across MDR, IVDR, MDSAP, TCP III and ISO 13485
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Combined audits for medical device certification
For medical device manufacturers managing multiple certification requirements, audit planning can quickly become complex. DNV helps manufacturers coordinate eligible audits across schemes such as EU MDR, IVDR, MDSAP, TCP III and ISO 13485 to reduce duplication, improve planning and support more efficient certification pathways.
Whether you are preparing for EU market access, maintaining global approvals, or aligning quality management system audits across multiple markets, a combined audit approach can help make the process more predictable.
One coordinated approach. Multiple certification needs
Medical device manufacturers often need to demonstrate compliance with more than one regulatory or quality management requirement. This can result in separate audits, repeated documentation reviews, increased pressure on internal teams and higher certification-related costs.
Where scope, timing and regulatory requirements allow, DNV can coordinate audits across multiple schemes, including:
This integrated approach supports a more efficient and cost-effective audit experience while maintaining the independence, rigour and scheme-specific requirements expected of an accredited certification body and Notified Body.
What can be combined?
MDR /IVDR & ISO 13485
For manufacturers seeking EU MDR certification, ISO 13485 quality management system certification may be assessed in a coordinated way where the audit scope and timing align. This can help reduce repeated review of overlapping QMS processes.
MDSAP & ISO 13485
MDSAP is built on ISO 13485 and includes additional regulatory requirements from participating jurisdictions. For manufacturers selling into multiple global markets, combining MDSAP and ISO 13485 audits can support a more streamlined quality system assessment.
MDR / IVDR & MDSAP
Where applicable, manufacturers preparing for EU MDR or IVDR certification may be able to align elements of their Notified Body assessment with MDSAP audit planning. This can be particularly valuable for organisations managing limited regulatory resources across multiple markets.
MDR / IVDR & MDSAP & ISO 13485
For manufacturers managing both EU and international regulatory pathways, DNV can assess whether MDR, MDSAP and ISO 13485 audits can be planned together. This may help reduce audit fatigue, improve internal preparation and create a clearer certification roadmap.
TCP III & ISO 13485
For manufacturers seeking market access in Taiwan, TCP III can be coordinated with ISO 13485 certification where scope and timing align. This approach can help streamline audit activities, reduce duplication and support efficient management of quality system requirements.
MDR / IVDR & TCP III & ISO 13485
Manufacturers pursuing both EU and Taiwan market access may be able to coordinate MDR or IVDR assessments with TCP III and ISO 13485 audits. This can help optimise audit planning, improve resource utilisation and support a more efficient certification pathway.
How the process works
- Share your certification needs: Tell us which schemes you are preparing for, your current certificates, target markets, device categories and preferred timelines.
- Scope review: DNV reviews whether the relevant schemes, device scope, audit timing and certification status can be coordinated.
- Audit planning: Where a combined approach is possible, we build a coordinated audit plan that reflects the requirements of each applicable scheme.
- Audit and Assessment: DNV conducts the audit in line with the relevant regulatory and accreditation requirements for each scheme.
- Certification decision: Certification decisions remain scheme-specific and are made according to the applicable requirements for each certification or conformity assessment route.
Is a combined audit right for you?
A combined audit may be suitable if you:
- Hold or are preparing for ISO 13485 certification
- Need MDSAP for access to participating regulatory markets
- Are preparing for MDR or IVDR certification
- Want to reduce repeated audits across similar QMS processes
- Are transferring certificates from another certification body or Notified Body
- Need better visibility across multiple certification timelines
Not every audit can be combined. Eligibility depends on scope, timing, scheme requirements, accreditation rules and the maturity of your quality management system.
Why DNV?
DNV is a trusted certification partner for medical device manufacturers worldwide. As a Notified Body for MDR and IVDR, an MDSAP Auditing Organisation, a TCP III certification body and an ISO 13485 certification body, DNV supports manufacturers across key regulatory and quality management pathways.
Our medical device teams combine technical expertise, regulatory understanding and structured project management to help manufacturers navigate complex certification requirements with clarity and confidence.
Frequently asked questions (FAQ)
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No. The possibility of combining audits depends on scope, timing, scheme requirements and the certification status of your organisation. DNV will review your situation before confirming whether a coordinated approach is possible.
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No. Certification outcomes remain separate and scheme-specific. A combined audit approach coordinates the assessment process where possible, but each certification decision is made according to its own requirements.
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Yes, in many cases ISO 13485 and MDSAP audit activities can be coordinated because MDSAP is based on ISO 13485 with additional regulatory requirements from participating jurisdictions.
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A combined approach may reduce duplication and improve audit planning, but audit duration depends on scope, device complexity, organisation size, sites, scheme requirements and regulatory rules.
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DNV can review transfer requests for eligible certifications. If you are considering transferring to DNV, we can assess your current certification status, scheme requirements and potential audit planning options.
Our certification services
MDR Certification | EU Notified Body #2460
Secure EU market access and navigate Medical Device Regulation (MDR) compliance with confidence through DNV’s expert certification services and global regulatory support.
Find out more about MDR certification
IVDR Certification | EU Notified Body #2460
Gain EU market access for your in vitro diagnostic devices with DNV, a designated Notified Body under the In Vitro Diagnostic Regulation (IVDR – EU 2017/746).
Find out more about MDR certification
MDSAP Certification
Streamline global market entry with DNV’s MDSAP certification. A single regulatory audit covering multiple jurisdictions helps medical device manufacturers achieve more efficient compliance across key markets.
Find out more about MDSAP certification
ISO 13485 Certification
Achieve global market access and regulatory compliance with confidence through DNV’s ISO 13485 certification services for medical device quality management systems.
Find out more about ISO 13485 certification
TCP III Certification
Secure a stronger position in Taiwan’s medical device market with DNV’s TCP III Certification, enabling faster, cost-effective compliance through coordinated EU–Taiwan conformity assessments.
Find out more about TCP III certification
Transfer your certification to DNV
We combine deep regulatory knowledge with industry-wide experience, enabling you to navigate complex requirements with clarity and confidence.
Switch your certification to DNV
Explore our resources
Want to ensure safety, compliance, and trust across the medical device lifecycle?
Download the Medical Device Certification brochure to learn more.
