We provide service for high quality regulatory consulting according to your needs

We can provide complete package for getting your medical software product ready for CE-marking and/or FDA 510(k) application. We are specialised in the regulatory framework for medical image analysis software and have more than 10 years of experience in the field. We offer a very broad and flexible regulatory consulting, everything from smaller consulting project, education to a complete regulatory package to take your product from idea to regulatory application.


  • Reduce cost by get a complete package for your company to implement quality system, train employees, provide you with templates and checklists to easily follow all regulatory requirements.
  • Save time by our efficient and optimized implementation plan
  • Added value for you company to have regulatory approvals
  • We support you in every step to ensure you get an efficient quality system adapted to your company structure

The regulatory training we offer aims to provide sufficient knowledge to enable you to implement the quality system in your business and apply the CE marking and/or FDA regulations for your product with good confidence.

With the templates, checklists and training included, we expect you to save many months of work and minimize the cost for the reviewing process by regulatory authorities. Following our well-prepared implementation process is cost-effective and time-efficient compared to find out everything on your own or have massive feedback from Notified Body / FDA in the review process. An implemented quality system that meets regulatory requirements is a great added value for the company, for example, in valuation and financing.

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