professional training

COMPLETE SET OF TRAINING PROGRAMS FOR REGULATORY AS WELL AS CLINICAL PROCESSES

We can offer you customized lectures, training programs, and workshops within a variety of areas and topics, all specifically adapted for your needs and products. We perform lectures and training programs for manufacturers, healthcare professionals and clinical study teams, universities and notified bodies – Regardless of who you are, we can provide you with the required knowledge.

 

Learning from real cases

Through our participation in technical committees, working groups and trade organizations, and our extensive experience from the medical device industry, we understand the challenges in dealing with the regulatory environment in the EU and US.

Our courses are based on our knowledge and experience. All of our trainers are subject-matter experts basing all aspects of their modules on practical examples from the real world.

We customize lectures, training programs, and workshops covering a variety of topics and tailor them specificly for your needs.

Our education services include:

  • Company sponsored studies
  • Physician initiated grant studies
  • CE-marking
  • Medical Device Directive (MDD) and Medical Device Regulation (MDR)
  • Develop a successful global clinical strategy
  • Post Market Clinical Follow-up (PMCF)
  • Clinical Evaluations according to MEDDEV 2.7/1 Rev.4

GET IN CONTACT

Whether you have questions regarding regulations, clinical strategies, educations or need help with an audit, you are always more than welcome to contact us.

Our ecosystem for full-service medical device compliance

We are your full-service medical device partners. Together we offer unique expertise regarding Quality Assurance, Regulatory Affairs, Clinical Affairs, Biological Evaluations & Toxicology.