Maximising value, lowering barriers


Designing products in a rapidly changing landscape

Over the last 3 - 5 years we have experienced a rapidly changing political and regulatory landscape in the UK, Europe and the United states. For device manufacturers this is changing the barriers to market and the potential size of those markets

We will work with you to evaluate these impacts on your device in the short, medium and long term, as this landscape evolves

Specifically, we can advise, contribute and lead on

  • The impact of Brexit on market traction and regulatory requirements
  • Planning for the MDR and IVDR
  • Risk management - business, resource, skills, project, product, supply chain etc.
  • Technical File and STED recompilation
  • Second sourcing and supply chain risk mitigation
  • Event impact assessment