Regulatory Affairs

HIGH LEVEL OF PROFICIENCY IN REGULATORY AFFAIRS AND EXTENSIVE EXPERIENCE

Regulations for medical devices differ substantially from those of pharmaceutical and drug development. With a high level of proficiency in Regulatory Affairs and extensive experience with EU and US medical device regulations, we are able to support you in handling challenges and questions arising throughout your medical device life cycle and help your company navigate regulatory requirements.

 

Latest insights on new regulations

Devicia is a member of multiple committees and trade organizations both in the EU and the US. As a nominated expert in the ISO/Technical Committee 194 Working Group 4, Devicia works with the globally recognized ISO 14155 standard governing clinical investigations of medical devices in humans.

Thus, we can provide you with the very latest insights on new regulations, as well as delivering strategic input for future trends in medical device requirements.

Our services include:

  • Strategic Advice
  • Education
  • Regulatory Affairs
  • Due Diligence
  • Person Responsible for Regulatory Compliance (PRRC)
  • Requirements related to Economic Operators
  • Quality Management Systems (ISO 13485, ISO 14155)
  • Audits
  • Post-Market Surveillance, incl. Post-Market Clinical Follow-up
  • Gap-analysis and interpretation of regulatory requirements
  • Project Management
  • Clinical Regulatory Expertise
  • Regulatory and Clinical Strategy, incl. clinical development strategy
  • Usability
  • Market Studies

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.

    Partners for full-service

    Together with Clarvin, Limulus Bio and Kickfile, we support all your needs, everywhere, every time. Irrespective if it relates to Strategic Advice, Quality Assurance, Regulatory Affairs, Clinical Affairs or Biocompatibility.