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.
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
Specific country applications / clearances