Medical devices


The medical devices sector includes a wide range of products used in the diagnosis, treatment and prevention of medical diseases and disorders. These products can range from simple surgical instruments to advanced technologies such as implantable electronic devices, diagnostic and monitoring equipment, and prosthetics. Regulations are becoming more stringent and safety and efficacy requirements are becoming more demanding.

At tri-consulting we have a team of professionals ready to provide the best advice and accompaniment in the process, we help you to have your Quality Management System ready according to the regulations required by the corresponding health authorities and we can even help you define and maintain a robust sterilization method according to your needs, either by beta, gamma or X-ray radiation, Autoclaving or EO.

  • Implementation and maintenance of GMPs and GDPs.
  • Audits to suppliers, CMOs and data integrity.
  • Advice on the design of clean rooms and the design and drafting of SOPs:
    • Personnel flow.
    • Materials flow.
    • Garments.
    • Cleaning and disinfection.
  • Validations:
    • Thermal.
    • SIPs.
    • Aseptic process.
    • Cleaning and disinfection.
    • Equipment cleaning.
      • Garments life cycle.


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