Dispositifs médicaux

Life cycle of medical devices

Have unique access to all the support you need throughout the life cycle of your devices

At each stage of your medical device’s life cycle, LCIE Bureau Veritas, with its experience in the evaluation of electrical and electronic equipment, provides you with its expertise to:

  • Validate your product’s reliability and safety
  • Proceed with the development or compliance of the technical documentation
  • Verify your organization’s structure or recent updates in accordance with the expected quality systems within the medical sector

System monitoring

Phase

Project Launch

Project Deployment

Commercialization

Technical Axis

  • Determination of applicable requirements

  • Analysis of the medical device build and detection of technical points for improvement

  • Help in the technical resolution of design issues

  • Education or training in the creation of a medical device’s technical file

  • Assistance in the development of the technical file (risk analysis, suitability for use, usage instructions, labeling, clinical data formatting, response to essential requirements, etc.)

  • Carrying out safety, electromagnetic compatibility, and radio tests

  • Technical file evaluation

  • Preparation of testing reports

  • Assistance in resolving technical and / or document non-compliance

  • Impact analysis of device’s design changes

  • Expertise in identifying product defects, searching for failure root causes

  • Technical file updates

Organizational Axis

  • Participation in building the quality system in accordance with the ISO 13485 standard

  • Familiarization with differences between ISO 9001 and ISO 13485

  • Training on medical sector requirements

  • Quality system upgrades

  • Upgrade of mandatory procedures related to the medical sector

  • Regulatory oversight

  • Assistance in resolving non-compliance

Medical devices

Medical devices

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CE labeling in the medical field

CE labeling in the medical field

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