DNV Enables Faster Global Market Access for Clearlab With Combined Medical Device Certifications

Cecilie Gudesen Torp, Global Director Medical Services, DNV and Hae Kyeung Park, Managing Director, Clearlab.

(IN BRIEF) DNV has certified Clearlab’s contact lenses and multi-purpose lens care solutions under the Medical Device Single Audit Program, ISO 13485, and the EU Medical Device Regulation through a parallel audit process. This integrated approach enabled Clearlab to achieve compliance with multiple regulatory frameworks simultaneously, reducing audit complexity and accelerating access to key global markets. The certifications confirm that Clearlab’s products meet international standards for quality, safety, and regulatory compliance, supporting faster global rollout and broader market reach.

(PRESS RELEASE) LONDON, 21-Jan-2026 — /EuropaWire/ — DNV has completed the certification of contact lenses and multi-purpose lens care solutions manufactured by Clearlab, confirming compliance with the Medical Device Single Audit Program, the ISO 13485 quality management standard for medical devices, and the European Union Medical Device Regulation 2017/745. The certifications enable Clearlab to strengthen its regulatory standing across multiple global markets through a streamlined assessment process.

The certifications were achieved through a parallel audit approach, allowing Clearlab to be evaluated against several regulatory frameworks at the same time. This coordinated method reduced both audit duration and administrative complexity, supporting a more efficient route to certification while maintaining rigorous safety and quality requirements.

Medical device manufacturers face increasingly complex regulatory environments, as market access often requires compliance with multiple national and regional frameworks. To address this challenge, regulatory authorities in Australia, Brazil, Canada, Japan, and the United States established the Medical Device Single Audit Program, built on the ISO 13485 standard. A successful MDSAP audit can provide access to these five markets, as well as additional affiliate jurisdictions. In parallel, compliance with the EU Medical Device Regulation enables market access across the European Union and the European Economic Area.

As an authorized MDSAP Auditing Organization and a designated EU Notified Body, DNV is permitted to conduct audits under both certification schemes. This dual authorization allows manufacturers to consolidate assessments and pursue access to major international markets through a more efficient certification pathway.

For Clearlab, the integrated audit covered requirements under MDSAP, ISO 13485, and the EU MDR in a single process. This approach minimized duplication, reduced the overall audit burden, and provided greater flexibility in planning global product launches. The outcome supports faster availability of Clearlab’s contact lenses and lens care solutions to customers across Europe, Asia Pacific, and other regulated regions.

The successful certification confirms that Clearlab’s products meet internationally recognized standards for quality management, product safety, and regulatory compliance. It also illustrates the growing importance of coordinated, multi-standard audits in helping medical device manufacturers navigate complex regulatory landscapes while maintaining high levels of patient safety and product performance.

Media contact:

Mona Ghobadi
Global Head of External Relations
+49040361497484
Mona.Ghobadi@dnv.com

Nurfarahin Mohd Johan
Senior Auditor, ISO13485 & MDR
Nurfarahin.Mohd.Johan@dnv.com

Lakshmy Gowrishankar
Head of Regional Marketing & Communications, APAC & Greater China
+656583180512
Lakshmy.Gowrishankar@dnv.com

SOURCE: DNV