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What We Certify

Certifications built on global standards

With the certification standards we offer, your business gains a competitive advantage and a framework to keep improving its processes and credibility. Each standard below has its own dedicated page.

Medical Device Regulatory Affairs

Medical Device Regulatory Affairs

EU MDR / CE Marking

Regulatory compliance and CE marking under the EU Medical Device Regulation.

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UKCA Certification

UK Conformity Assessed marking for the Great Britain market.

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MHRA Registration

Registration with the UK's Medicines and Healthcare products Regulatory Agency.

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FDA Registration

US FDA Establishment Registration & Device Listing for medical device manufacturers.

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510(k) Submission Support

Premarket notification support for US FDA clearance.

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EUDAMED Registration

Registration on the EU's medical device database.

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UDI / Basic UDI-DI Assignment

Unique Device Identification assignment for regulatory traceability.

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Swiss Authorized Representative

Representation service for medical device manufacturers placing products in Switzerland.

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UK Responsible Person

Responsible Person service for medical devices placed on the UK market.

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Australian TGA Registration

Registration with Australia's Therapeutic Goods Administration.

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Saudi SFDA Registration

Registration with the Saudi Food and Drug Authority.

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ANVISA Brazil Registration

Medical device registration with Brazil's health regulatory agency.

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Philippine FDA Registration

Medical device registration with the Philippine FDA.

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EAEU Registration

Medical device registration across the Eurasian Economic Union.

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ARSA Honduras Registration

Medical device registration with Honduras's health regulatory authority.

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Not sure which standard fits?

Tell us about your organization and we'll help you work out the right standard — or combination of standards — to pursue.