Regulatory strategy

Navigating the regulatory and quality management landscape around the world can be challenging and overwhelming, and it tends to change, continuously.

QAdvis has extensive experience and local networks to cover the regulatory and quality requirements in EU, USA, China, Taiwan and Canada (among others).

A comprehensive regulatory strategy includes:

  • Determining if your product is a medical device
  • Identifying the medical device class (EU, US, Canadian, etc.)
  • Identifying the GDMN code or product code (US)
  • Identifying predicate device(s) (US)
  • Identifying required standards for design or manufacture
  • Identify the need for clinical data

Early identification of requirements can save you both time and money, getting your product on the market as soon as possible.

Contact me for further information
Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail