QHSES & Compliance Quality – QMS Medical Devices

Project

  • Management of the quality manual and the Master File site
  • Management of quality documents (drafting, review and archiving): policy, processes, procedures, templates and instructions based on the activity carried out
  • Staff training on documents
  • Training for internal, external and inspection audits
  • Management of non-compliance/anomalies/incidents/deviations, CAPA and complaints
  • Management reviews/product quality/quality approval
  • Change and risk management

Challenges

  • Quality : 4/5
  • Cost : 2/5

  • Deadlines : 3/5
  • Security : 5/5

Delivery

  • Definition of user needs
  • Preliminary design (studies, planning)
  • Writing and updating of documents
  • Exchange control, claims and CAPA management
  • Product control
  • Process/product risk analysis
  • Support in implementing and monitoring indicators
  • Regulatory watch

Summary

Project duration

12

months

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Expertise

SMQ

ISO 13 485

Biotechnology industries

DM manufacturers

QHSES & Compliance

Fabrication shop risk assessment

16/12/2021

paul

QHSES & Compliance

Fabrication shop risk assessment

06/12/2021

paul

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