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Health Care Regulatory Explorer

Medical Device Regulatory Support - 24x7

From concept to launch - Regtik delivers correct, fast regulatory guidance on medical device qualification and classification. 

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Our easy-to-use platform lets you explore the regulatory landscape and find out how design decisions can change your regulatory options. Find out in minutes:

  1. Qualification – whether your product counts as a regulated medical device
  2. Classification – the risk class of your  medical device (e.g. Class I, IIa, IIb, III) under the regulations
  3. Regulatory pathways – the steps you need to take to go to market in the UK, EU, USA and Australia

We know that early stage concepts can change – you can run product changes through the system as often as you like at no extra cost.

Use our AI-powered guidance to build a regulatory strategy for licensing and launch across key global markets: the UK, EU, USA and Australia.

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Start exploring with Regtik