Medical Device Certification
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Please fill out the form below to learn more about our medical device regulatory compliance services or to get in touch with an SGS representative.

Why SGS?

We are the world’s leading testing, inspection and certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals.

Comply with medical device regulations to enhance product quality and safety, enter markets and improve patient treatment.
Most Conformity Assessment Bodies are overwhelmed and capacity-constrained. These delays in certification can cost manufacturers valuable time and market opportunity.

Fast-track your medical device certification – we’re ready when others aren’t

ISO 13485 Certification - Medical Devices QMS

Ensure your medical device quality management system (QMS) meets ISO 13485 certification requirements. ISO 13485 is a mininum requirement for medical device manufacturers and it is at the core of international market access programs, such as MDSAP, CE and UKCA markets. We independently assess your QMS against ISO 13485 and provide certification required for market access.

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Medical Devices Regulatory Compliance Services

Medical Device Single Audit Program (MDSAP)

MDSAP enables medical device manufacturers to undergo a single audit that is accepted by MDSAP member countries. Confirm your compliance with the requirements of medical device auditing programs for Australia, Brazil, Canada, the US and Japan, with our MDSAP services.

Medical Device Regulation (MDR) Certification

All medical devices certified under the Medical Device Directive (MDD) must certify to the EU MDR 2017/745 to ensure they can continue to be sold in the European market.

Orthopaedic & Dental MDR/UKCA Services

To access European and UK markets, orthopaedic and dental device manufacturers must be approved by the relevant regulatory body. For the EU, manufacturers must follow MDR and be certified by a Notified Body to use the CE Mark. The UK requires UK MDR certification by an Approved Body to apply the UKCA Mark.

Software as a Medical Device Certification

Many medical devices rely on software to ensure efficacy, safety and quality, and software in the medical device industry represents a rapidly expanding area in healthcare. The MDR and UK MDR have special technical restrictions for software. We help certify your SaMD.

UKCA for Medical Devices & In Vitro Diagnostic Medical Devices

To place medical devices or in vitro diagnostic (IVD) medical devices on the Great Britain market (England, Scotland and Wales), you must comply with UK MDR regulations as well as requirements set out by the UK's MHRA. Access Great Britain's medical devices and IVD medical devices markets with UKCA.

Medical Device Supply Chain Services

Disruption at any point in the medical device supply chain can impact production and market delivery. Reduce risks, optimize your supply chain and ensure safe product delivery with our medical device supply chain services.

Medical Devices Training

SGS Academy offers introductory, evaluation and implementation courses based on regulatory benchmark core principles. Learn how certification works in practice and apply your learning in subsequent validation processes. Our virtual training sessions are offered publicly throughout the year.

Transfer your certification for FREE

Transfer your IVDR, MDR, UKCA or MDSAP certifications for free.