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• News and events
  • 2018
• About LNE/G-MED
  • Brief history
  • Legal status
  • Organization and management
  • Activities
  • G-MED North America
  • Addresses & Contacts
• Services
  • CE marking
  • Certification of Company Management Systems
  • Quality certification of sterilization processes
  • MDSAP certification
  • Access to the American market
  • Access to the Taiwanese market
  • Access to the Australia and New Zealand markets
  • Access to the Japanese market
  • Medical equipment :
    CB Scheme certification
  • Product certification
  • Training
• Applying for certification
  • How to obtain certification
  • Receive a detailed proposal
  • Additional information
• Certified companies or bodies
• Recognition and accreditation
• Guides
  • CE Marking : Dealing with changes in medical devices
  • IEC 60601 3rd edition
  • Electromagnetic Compatibility (EMC)
  • Registration medical device in Brazil
  • Japanese Medical Device Approval Process
  • How to change your Notified or Certification Body
  • Presentation of biological evaluation According to ISO 10993-1
• Links to key sites
• FAQ

Training

To allow you to be well informed about the relevant regulation and technical issues, acquire the high level of expertise necessary to remain competitive, and design innovative products that meet the regulatory requirements, LNE has selected 10 training courses, responding to two key issues :

Medical Device Manufacturers - To know and implement the regulation :

• Medical Device Regulation in the USA (FDA) - SA15
  Preparation of 510 (k) submissions
• In Vitro Diagnostic Medical Devices - SA18
  Prepare the technical file and demonstrate the compliance with the requirements
• European regulation on medical devices - SA25
  Directive 93/42/EEC
• Building the EC marking file case - SA43
  Content of the technical file in accordance with the requirements of the directives 93/42/EEC and 90/385/EEC (and their latest amendment, directive 2007/47/EC)
• EC Marking of In Vitro Diagnostic Medical Devices : the regulatory changes - SA50
• New European regulation on medical devices - SA56

Medical Device Manufacturers - To manage risks :

• Biocompatibility of medical devices - SA21B
  Risk Management
• Master the sterilization of medical devices - SA27A
  Validation of sterilization by irradiation
• Master the sterilization of medical devices - SA27B
  Validation of sterilization by ethylene oxide
• Medical device software life cycle processes - SA36
  How to meet regulatory requirements
• Magnetic resonance imaging (MRI) compatibility - SA48
  Integrate MRI compatibility constraint in medical devices