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Medical Devices

No matter what the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market quickly whilst ensuring compliance with the required regulations and standards.

As the world’s largest inspection, verification, testing and certification company, we provide clients with a market-leading, global network of medical device offices, laboratories and experts. Operating in over 35 countries, we offer global and local solutions to meet your certification, testing, training and audit requirements. We offer virtually every global approval you need now or will need in the future.

Certification: ISO 9001, ISO 13485, EC Directive 93/42/EEC (MDD), EC Directive 98/79/EEC(IVDD), CMDCAS (Canada), JPAL (Japan), INMETRO (Brazil), FDA Accredited Persons Program, Good Distribution Practice, with additional regulatory approvals for Taiwan, Hong Kong, Australia, Korea, Saudi Arabia and others.

Electro-medical Testing: Product safety and EMC testing to the full range of IEC/EN 60601 and IEC/EN 60110series with CB, NRTL approval and ISO 17025 accreditation.

Microbiological and Pharmaceutical Testing: Sterility, biocompatibility, bioanalytical.

Other Testing: Wireless/Telemedicine. Battery, RoHS 2, Packaging.

Training: QMS/Auditing, Internal Auditing, Global Regulations, Sterilization processes, Risk Management, Product Safety/EMC with public and in house courses.

Auditing: Supplier audits, gap analysis audits, pharmaceutical GMP audits.

Let SGS facilitate your access to global markets and support your supply chain and risk management. 

Enabling Enquiries

When completing our enquiry form please select Industry-Life Sciences and start the ‘How can SGS help’ box with the words ‘Medical Devices’ to ensure a quick response from our experts.

Transforming people and businesses with the SGS Academy

As the global leader in professional training, we offer worldwide centers of excellence, providing the very best learning and development solutions customized to your exact needs.

We have a proven track record, delivering public, in-house and online courses for the world’s largest companies and government organizations. Plus, with expert trainers that are experienced practitioners in their field, our training moves beyond theory, giving you valuable real-world insights. As a result, you can trust us to provide high-quality consistent training and development at every level of your organization – anywhere in the world.

Whatever your industry, whatever the subject, contact us to find out how the SGS Academy can help you.

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Medical Devices Brochure Medical Devices Brochure Audits, Certification & Training ...
IVD Medical DevicesWhite PaperIVD Medical Devices White PaperAbout EC DIRECTIVE 98/79/EC-IVD Medical Devices
Medical DeviceRegulations White PaperMedical Device Regulations White PaperAbout MD market entry regulations in 13 main markets (PDF 2.55 MB) ...

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SGS Headquarters

  • 1 Place des Alpes
    P.O. Box 2152
    Geneva, 1211
    Switzerland
  • t   +41 22 739 91 11
  • f   +41 22 739 98 86
  • e   Email us

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