Expert Consultants You can Trust


MDR Consultants strives to provide you with proven, trusted, and cost-effective solutions.


Our consultants have years of experience working for Notified Bodies and leading medical device companies that implement these practices; this knowledge allow us to offer you solutions tailored specifically to your needs while ensuring compliance and conformance with applicable standards and regulations and at the same time, increasing efficiency and effectiveness of your organization that will certainly reduce your costs.


MDR Consultants can support a wide array of medical device related needs, including but not limited to:

  • Training
  • QMS transition to the EU MDR, MDSAP, or UKMDR
  • Implementation of ISO 13485:2016
  • Implementation of ISO 14971:2019
  • Gap Analysis
  • Design and Development of products from idea to market
  • Risk Management
  • Quality Management System Procedure(s) Generation
  • Pre-market Submissions and Licensing (PMA, 510k, Registration, EUDAMED, MHRA, etc.))
  • Technical File Generation and Maintenance
  • Clinical Evaluations
  • Post Market Surveillance
  • Vigilance
  • Remediation Projects or Initiatives
  • 483 Response



Book a FREE consultation today

and let us discuss your needs and the ways we can help you achieve your goals.


Quality Management System
ISO Statutory
MDD (European Union)
ANVISA (brasil)
PMDA (Japan)
MDALL (Canada)
TGA (Australia)
TGA (Australia)