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.

Medical Devices ServicesBrochureMedical Devices Services brochureFind the most reliable route to the market (PDF 175KB) ...

IVD Medical DevicesWhite PaperIVD Medical Devices White PaperAbout EC DIRECTIVE 98/79/EC-IVD Medical Devices

Electro-Medical DevicesBrochureComplete Global Solutions for Electro-Medical DevicesGet your product to market faster. We know the way. ...

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