Veranex 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 location is ISO 13485:2016 certified.
Our Providence office also maintains compliance with 21 CFR part 820.
Clinical Data Services
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.
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).
- Veranex Paris Lab has all the authorizations and is fully accredited from the relevant French regulatory institutions in order to practice animal research.
• Veranex Paris Lab 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.
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