Regulatory Strategy & Transition Planning

For new devices we support the definition of regulatory strategies and plans from proof of concept (POC) to market clearance in your chosen territory. With you, we plan device design & development, environment controls to meet ISO 14644, manufacturing / assembly, (including contract manufacturing), packaging & labelling / UDI, sterilisation and change to regulatory applications and product launch & distribution.

For existing devices, we support manufacturers, distributors and other economic operators to establish effective MDD / IVDD to MDR / IVDR transition planning to address and meet the new  EU regulations (EU) 2017/745 (MDR) & 746 (IVDR), new EN / ISO standards and/or common specifications. This support extends to Notified Body selection and / or change.

Providing expert resources to advise, develop, plan, implement best fit practices and controls for:

  • POC including technology application re: clinical need, indications for use and application

  • Specification development, definition, including User and Interface Requirements

  • Risk Management planning & identification of national and international standards for test

  • Notified Body Application / Change

  • Materials specifications & selection

  • Materials testing protocols including characterisation, biocompatibility, physical / mechanical / chemical  attributes

  • Clinical Evaluation

  • Specific country applications / clearances

  • PMS & Vigilance Planning

C L i C for Support