Regulatory Strategy & Transition Planning

With you we define strategies and plans for proof of concept (POC), device development, material selection, manufacturing / assembly, packaging & labelling, sterilisation, testing and change. We support you, and all economic operators address and meet the new EU regulations (EU) 2017/745 (MDR), 746 (IVDR), new standards and/or common specifications.

Supporting you with expert resources, advices, planning and development to mplement 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

  • Software Life-Cycle to meet IEC62304

  • Regulatory Strategy
  • Planning
  • Clinical Application
  • Intended Use
  • Patients and Users’ Requirements
  • Usability Factors
  • Materials and Biocompatibility
  • Regulations and Standards
  • Testing
  • Proof of Concept (POC)
  • Technical Documentation
  • Compliance Routings
  • Classification(s)
  • Notified Body Applications
  • Evidence for Design Input
  • Project Management

Would you like to know more?

We commit to help  you with any enquiry; you can complete the contact form or contact us on one of the following: