Medical devices - Regulatory Services

Medical devices - Regulatory Services
Product Description

- MDR &IVDR CE certification - Data Gap analysis - Technical Documentation - Clinical & Biological evaluation - Risk management (ISO 14971) - Performance evaluation - PMS Plan & Report, PMCF Plan & Report, PSUR, PMPF - Vigilance - EUDAMED - National registration services - Economic operators’ compliance support - Training -Liaison with Competent Authorities and Notified Bodies

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Sustchem S.A.

  • GR
  • 2022
    On CPHI since
View company profile
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Sustchem S.A.

  • GR
  • 2022
    On CPHI since
View company profile

More Products from Sustchem S.A. (2)

  • Medical Writing & Toxicological Reports

    Product Medical Writing & Toxicological Reports

    - PDE - OEL - Clinical and non-clinical overviews - Environmental Risk Assessment
  • Pharma Regulatory Services

    Product Pharma Regulatory Services

    - Pre- and Post- Authorization Consultancy - Marketing Authorization Applications (NAP/DCP/MRP) - Life Cycle Management (renewals, variations etc.) - Submission of regulatory – related documents to Health Authorities - e-CTD submissions

Sustchem S.A. resources (1)