Medical Device

The regulation of Medical Devices and Health Products enforces thoroughness in the application of the regulations and the generation of supporting documentation.

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The demanding regulatory framework for Medical Devices, currently in the process of change, requires a high level of control over all phases of the product life cycle in order to guarantee patient and user safety (design and development, Product commercialization, production, storage and distribution, installation, service and removal).

We can help you in the following areas:

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  • Regulatory advice
    • Implementation of new regulation MDR (EU) 2017/745
    • Implementation of new regulation IVDR (EU) 2017/746
    • Medical Device Classification
    • CE marking
    • International product registration including FDA 510 (k)
    • MDSAP
    • Preliminary license to operate facilities
  • Consulting and implementation of Quality Systems according to ISO 13485 and 21 CFR 820.
  • Risk Analysis and Management according to ISO 14971.
  • Advice on the preparation of technical files.
  • Clinical evaluation.
  • Audits.
  • Equipment qualification
  • Training
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  • Software validation:
    • Software considered Medical Device
    • Software with an impact on product quality.
    • Mobile Apps

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