Market your medical device in Europe and the US: fast and legally

60+ instructional videos guide you to CE-mark and FDA approval

Getting approval for the European and the US market can be time consuming and expensive. 60+ instructional training videos provide step-by-step guidance to

  • accelerate the time to market (Europe, USA) for your medical device:
    The videos and templates help you avoiding project delays (e.g. due to re-submissions), quality bureaucracy and unnecessary documentation.  

  • get rid of expensive consultants:
    Getting familiar with regulations can be time consuming and exhausting. We did that for you, prepared templates and provide simple step-by-step guidance. Medical device law is not as complex as it looks like. No consultants need, even not us :-).

  • avoid difficulties in audits, reviews and inspections:
    The video trainings explain the regulations and help compiling submission documents and establishing quality management systems. All(!) of our clients (several 100) passed audits/inspections without any major non-conformity.

  • develop safe products:
    The training videos not only explain how to meet regulatory requirements but also to professionally develop safe and high quality medical devices. This is our duty, this is what we get paid for.

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Target group

The instructional training videos provide guidance for medical device manufacturers and suppliers:

  • System and software developers, system and software architects, engineers
  • Regulatory affairs experts
  • Quality managers
  • Risk managers
  • Project managers
  • Product managers

Content: What you will learn

The e-learning program contains anything companies need to compile submission documents and to pass quality management inspections respectively audits. Read more about the content