Consulting Services


Allow us to help you to jump through the hoops of regulations and untangle the webs of compliance that lie on the path to Medical Device certification

We can help you


Start-up and small companies may not always have the specialist skills and experience needed for Medical Device design. New products are often developed in an environment that concentrates on the basic engineering, feasibility and proof-of-principle studies. Early consultation ensures appropriate planning and aligns the design to the applicable regulatory constraints. Experienced resources will help to anticipate the issues that will arise during the transfer of the product design to full production and into the market.

Services Provided


  • Technical and Project Management of design-for-manufacturing process
  • Provision of manufacturing, distribution and service processes
  • Protocols for V&V, usability, production and service testing
  • Management of Design Transfer process
  • Creation of regulatory documentation to control product realisation
  • Risk Management and assembly of reports for filing
  • Project Management of product safety certification to IEC 60601
  • Strategy and management of CE and UL marking
  • Training, coaching and mentoring of staff on the above

+44 (0) 7801 017 892