Regulatory Toolbox
MDR
EU regulation that sets stringent requirements for the safety, efficacy, and quality of medical devices to ensure better protection for patients and users.
IVDR
EU regulation that establishes strict requirements for the safety and performance of in vitro diagnostic devices to enhance patient safety and ensure reliable diagnostic results.
FDA
The most influential regulatory agency in the United States, responsible for ensuring the safety and efficacy of food products, pharmaceuticals, and medical devices.
Clinical Study
Herein are assembled the regulations, guidelines, and educational materials pertinent to Clinical Study.
Human Factor
Herein are assembled the regulations, guidelines, and educational materials pertinent to Human Factor
R&D
Herein are assembled the regulations, guidelines, and educational materials pertinent to design and development.
Trusted Resources
We provide certain lists for your reference, but this does not imply our endorsement of the companies listed. If you need help finding reliable partners we have worked with, please contact us.
EU CRO List
Usability Testing Labs
MD Testing Labs
Contact us for trusted resources
