Assistance and Assessment in the Medical sector

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Bannière - Assistance and Assessment in the Medical sector

Guiding you all along the product life cycle  

LCIE Bureau Veritas has a strong experience for the assessment of electrical and electronic devices.

As such, you can rely on the LCIE Bureau Veritas expertise at each step of the product life cycle.

We offer you guidance for the following topics:

  • Assessment of the reliability and of the safety of your device
  • Construction or conformity assessment of the technical file
  • Verification or upgrade of your company organization, according to the quality system that is required by the healthcare sector.

 

Step Project Launch Project Implementation

Placing on the market and follow-up of the device

Technical axe
  • Determination of the applicable requirements
  • Construction review of the medical device and detection of the technical issues to be improved
  • Technical guidance for solving design issues
  • Sensitization or training for building the content of a medical device technical file
  • Guidance for the elaboration of a technical file (risk analysis, usability, instruction, labelling, clinical data set up, answers to essential requirements …)

 

  • Samples testing : safety, electromagnetic compatibility, radio
  • Evaluation of technical file
  • Test reports
  • Assistance for technical or documentary non-compliances

 

  • Analysis of the the modification impacts of the device design
  • Expertise on failed products, analysis of the root causes
  • Update of the technical file
Organizational axe
  • Participation to the construction of the quality system according to ISO 13485 
  • Familiarization with the differences between ISO 9001 and ISO 13485
  • Training to the requirements related to healthcare sector.
  • Upgrade of the Quality system
  • Upgrade of the mandatory procedures, related to the transition of the healthcare sector
  • Regulatory watch
  • Assistance for the resolution of non-compliance issues

 

 

 
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