Regulatory Affairs

Key2Compliance® offers a comprehensive global service portfolio within Regulatory Affairs (RA). Our specialists help you through the entire regulatory process, from idea to market, in exactly the way you need, fully adapted to your needs.

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We solve your regulatory needs, in the way that suits you best

The regulatory landscape in the medical device industry has been constantly evolving and changing in recent decades. In the future, there will be new regulations that place even higher demands on medical devices. As the regulations differ between different markets, it is important to be active and stay up to date at all times. As specialists, this is something that Key2Compliance® can help you with.

Our specialists have extensive experience of helping and supporting medical device companies with every regulatory issue. We have knowledge of the regulations and quality requirements within the EU, the USA and many other countries. 

With our specialist knowledge in several areas, we assist you in a flexible and customer oriented manner throughout the whole product life cycle, from idea to market. 

We can enter into the role as RA manager within your organisation and lead your regulatory work. We can provide RA consultants who help you carry out the work on site with you. If you wish, you can also let our in-house consultants run the projects and assist you from our offices. We help you with both minor and major assignments completely based on your needs.

Key2Compliance® helps you to:

  • Plan and implement different phases in the product life cycle, feasibility studies, development, post market, etc.
  • Carry out product qualification classification against current regulations
  • Identify and develop the necessary standards for process, design and manufacturing
  • Create instructions and guide documents
  • Identify product codes, such as GDMN codes
  • Manage risks and usability
  • Identify the need for clinical data
  • Make GAP analyses of your technical files
  • Identify, produce, upgrade or complete technical documentation
  • CE mark products
  • File FDA applications
  • Register your Medical device/IVD products worldwide
  • Carry out regulatory due diligence
  • Increase knowledge of the regulations in the EU, USA and other parts of the world