Triune Medical Technologies

Bringing innovative medical and healthcare solutions to the MedTech industires

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Triune Medical Technologies (Triune MediTech) is a medical technology focused and innovation driven company principally involved in providing expert technical advice and consultancy in medical and healthcare technology industries worldwide.
 

Triune MediTech is a Regulatory Affairs and Project Management Consultancy based in Cambridgeshire, providing both off-site and on-site support managing long term and interim projects for a variety of clients ranging from large multinational pharmaceutical and medical device organisations to SMEs taking innovative products to the EU and other global markets.

 
Triune MediTech strives to achieve excellence with incessant research and development projects to produce innovative high quality medical and healthcare products and services. We collaborate with the best consultants, manufacturers and researchers on projects in the medical and healthcare industries to bring innovative medical technologies to the market place. Areas of active services include:
 

  • Regulatory Affairs (Submission and Compliance)
    • CE Mark, Own Brand Labelling 
    • FDA 510(k) & PMA Submissions

  • Product Design and Development
  • Clinical Evaluation Report
  • Quality Management Systems
    •  ISO 9001 (for Product and Service Quality Improvement)
    • ISO 13485, FDA QSR, 21 CFR 820 (for Medical Device Regulatory Compliance)
  • Environmental Management System, ISO 14001
  • Risk Management (ISO 31000, ISO 31010, ISO 14971)
  • Project Management (ISO 21500)

  • Document Management Systems
  • Instructions For Use (IFU) / Operating Manuals preparations for Regulatory Compliance

  • Labelling Regulatory Compliance (to MDD, EN 980, ISO 15223)

  • Post Market Surveillance and Vigilance

 

Our team of dedicated experts in their respective areas of operation will provide the services you need and give you the support and guidance where needed throughout any project we embark on.  

 Training Courses

 

 

Our practical training courses are designed with your personal professional development and organisational development goals in mind.

 

Whilst some courses are industry-specific, others are generic and applicable to all industries and organisation of all sizes. Click here for more information

 

 
Got an innovative Medical Technology idea or project? Talk to our experts! >>

Triune Medical Technologies

22 Pennington Road, Hartford, Huntingdon, Cambridgeshire PE29 1QF, United Kingdom
E-mail: Info(at)triunemeditech.net           Telephone: +44 (0)1480 456 113           Skype ID: triunemeditech           eFax: +44 (0)700 600 6344