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 qualify as a medical device in the target market
  • Identifying the medical device class (EU, US, Canada, 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
  • Map and outline required regulatory efforts and activities sequenced over markets and over time to form a suitable strategy

Early identification of requirements will save the organization time and money, getting the product on the market avoiding unpleasant surprises.

Contact me for further information
Nils-Åke Lindberg
Office +46 8 621 01 05 or send me an e-mail