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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?
As a world leader in assessment, auditing and certification, our global network of experts offers comprehensive support. With specialists worldwide, we ensure your compliance with diverse international standards. Our services are delivered by our EU Notified Bodies and UK Approved Body, ensuring robust, transparent assessments and a competitive edge through regulatory trust.
Navigating the transition of medical device certification in the EU is complex and time sensitive. With most Notified Bodies overwhelmed and capacity-constrained, delays in certification can cost manufacturers valuable time and market opportunity.
ISO 13495 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. SGS will independently assess your QMS against ISO 13485 requirements and provide certification required for market access.
Medical Device 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 United States, and Japan, with SGS's MDSAP services.
Medical Device Regulation (MDR) Certification
All medical devices certified under the Medical Device Directive (MDD) must certify to the new requirements of 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 certification by an Approved Body to receive 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 health care. The MDR has special technical restrictions for software. SGS can help to 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 UKCA mark regulations as well as requirements set out by the UK's MHRA. Access Great Britain's medical devices and in vitro diagnostic medical devices markets with UKCA.
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.
Fast-track your medical device certification – we’re ready when others aren’t
In Vitro Diagnostic Medical Device Regulation (IVDR) Certification
SGS is a designated IVDR Notified Body. We can perform conformity assessments against IVDR in your country. Our expert auditors and product assessors can support you in bringing a wide range of IVDs to the EU market.
Shift delayed projects from other NBs to us to keep your timelines on track and for a limited time, transfers are deeply discounted to make it easier to make the move.
Our newly established, dedicated IVD team is fully equipped and ready to take on new projects. Our Dental and Orthopedic MDR team is also accepting new clients.
Unlike many NBs facing backlogs, we have ample capacity and deep expertise to provide faster, more efficient turnaround times - helping you enter the EU market without delay.