No matter what the size of your business, SGS medical device testing and medical device certification services can help you navigate the complexities of the medical device market and bring your product to market as quickly as possible without getting stalled by regulatory issues or medical device standards.

When you work with SGS, you have access to the knowledge and experience we have gained from an international network of laboratories and offices, staffed by experts who not only are in touch with the latest developments in their field, but also have a reputation for giving technically correct advice and helping clients cope with regulatory intricacies – both international and local.

Our experts can help you design and develop a comprehensive medical device program, drawing on our services in:

• Certification
• Training
• Quality control testing
• Electro-medical Equipment Testing
• Regulatory affairs and device vigilance
• Clinical trials

Testing and certifications are based on international and local guidelines such as: EMEA, AAMI, ISO, FDA, GCP, GLP, USP, and so on.

Our experts are available to discuss how we can help you get your product to market sooner.

Training location:  Scandic Simonkenttä, Helsinki 
Duration:  1 day

Target group

Planners, manufacturers and suppliers of electromedical equipment.

Time and place

February 29, 2012, 9.00 – 16.00 hours
Scandic Simonkenttä, Simonkatu 9, 00100 Helsinki

Target and content

The target of the seminar is to give a general view of how the buyers can make sure that the products they buy are safe and in conformity with the requirements.

Topics

• IEC 60601-1, 3. ed/EN 60601-1-1:2006
  • what is new
  • implementation schedule in Europe and rest of the world
• New Amendment 1 – content and schedule
• Collateral and equipment-specific additional parts of the standard
  • use, schedule, agenda
• IECEE CB Scheme  - a gateway to the international market
• Case; Implementation of new requirements