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Global Regulations

When you enter new markets – or the authorities introduce updated and new regulations – it is important that the knowledge of your management, staff and consultants is current. SGS’s medical devices regulations training will keep you up to date with legislation, and help your organization to remain competitive.

To help your organization, we offer medical devices regulations training at auditor, quality professional, compliance engineer and general levels. Training is often needed to allow management to fully understand the business implications of a new market or regulation. Additionally, it can help customers and consultants to write and amend quality documents, to assist in the compilation of technical files and act as an introduction to new members of the quality or regulatory department.

Typical courses and their durations in this area may include:

  • Requirements of 93/42/EEC, CE marking of medical devices (1day)
  • Requirements of 98/79/EC, CE marking of in vitro diagnostic medical devices (1day)
  • Technical Documentation for 93/42/EEC (1 day)
  • Technical Documentation for 98/79/EC (1 day)
  • Canadian Medical Devices regulations (0.5 day)
  • Regulatory requirements in Australia, China, Hong Kong, Japan, Korea, Taiwan (and more)

We can provide medical devices regulations training either as public courses or as customized in-house training. All courses are presented by our own industry experts. Global approval of medical devices regulations training is available in every region from your local SGS medical device office. Courses can often be arranged in your local language.

Our practical training is frequently updated and will help your organization achieve regulatory or certification approval. As a by-product, training can also provide ongoing improvements to your processes and products development.

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Medical DevicesBrochure Medical Devices: Find the Fastest and Most Reliable Route to Market 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)


SGS North America Inc.
Consumer and Retail

  • Suwanee Laboratory
    620 Old Peachtree Road - SUITE 100
    Suwanee, Georgia, 30024
    United States
  • t   +1 770 570 1800
  • f   +1 770 277 1240
  • e   Email us


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