Medical Device

Offering strategic and regulatory advice to our clients with the aim to navigate the regulatory landscape with the complete product lifecycle and business opportunities in mind. By including the regulatory aspects early on in the project, the path to market access can be influenced and time to market minimized.

By combining the understanding of regulatory demands and market dynamics with scientific knowledge we identify the critical steps to be performed. As part of your project team, we will analyze the regulatory environment and precedence, scientific basis and current regulatory thinking. We support in defining the regulatory plan and path to compliance and market access. We assess the need for clinical data and development plans from a regulatory perspective; identifying opportunities and issues and providing a regulatory strategy moving forward.

Our services may include:

  • Support in product definition, classification and path to compliance.
  • Define overall regulatory strategy and efforts to become compliant.
  • Regulatory review in relation to e.g. investment decision.
  • Planning, preparation and application of regulatory submissions (EU and US).
  • Suggest way forward regarding QMS and processes.
  • Review safety/risk work and testing performed, and define strategy to become compliant.
  • Support in compiling clinical evaluation report and technical documentation.
  • Support in classification to decide on significant change or not.