CERTIFICATIONS

With Veranex, your medical device development pathway is optimized to help you realize your innovation and growth objectives so you can deliver real advances in clinical care that make a difference for patients. Veranex and our legacy companies are certified throughout our business units.

Product Design & Engineering

Our Providence, Plymouth, and Orange locations are ISO 13485:2016 certified.

Our Providence and Plymouth office maintains compliance with 21 CFR part 820.

Data Management & Analytics

Veranex Inc., has implemented a strong quality management system and security posture based on the principles of the CIA (Confidentiality, Integrity and Availability) Triad for information security.

Regulatory Affairs & Quality Management

Our consulting and training services on regulatory affairs, quality management and clinical affairs for medical devices and in-vitro diagnostics manufacturers are ISO 9001 and ISO 13485 certified.

Preclinical Services

  • Last audits performed by the FDA in 2013 with a positive outcome: No concerns raised by the inspector.
  • Strong experience of preclinical studies prepared for FDA and European Notified Bodies.
  • All studies are performed according to basic “good practices” which imply high quality standards. Moreover, studies can be performed according to Good Laboratory Practice (21 CFR part 58).
  • IMMR has all the authorizations and is fully accredited from the relevant French regulatory institutions in order to practice animal research.
    • IMMR has all the authorizations and is fully accredited from the relevant French regulatory institutions in order to practice animal research.

     

    Main Certificates and Guidelines:

    • Agrement de la Prefecture
    • FDA
    • Compacts Regs™ Part 58
    • AAALAC International accredited program

      Animal Care Policy:

      • Fully accredited by AAALAC International.
      • Preclinical research is at the level of practicing veterinary medicine: all studies and procedures are supervised by veterinarians (13 DVMs on staff).
      • A Senior Veterinarian fully dedicated to animal care.
      • Careful Ethics Committee oversight.