Regulatory Strategy & Transition Planning

GPB provide assistance to define strategies and plans for proof of concept (POC), device development, manufacturing / assembly, packaging & labelling, sterilisation and change. In addition, we provide the support to enable transition planning and support manufacturers, distributors and other economic operators address and meet the new EU regulations (EU) 2017/745 & 746 and new standards and/or common specifications.

Regulation - GPB

GPB provide the necessary 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

  • Identification of national and international standards for test

  • Materials selection and testing protocols

  • Clinical Evaluation

  • Specific country applications / clearances

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