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Outcome-Driven Solutions for Medtech Challenges

Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.

Purpose-built solutions. Proven results. User & Patient-centered innovation.

 

Purpose-Built for Breakthroughs

Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity.  Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.  

We are the Innovation CRO.

Legacy of excellence. Proven execution. Patient impact accelerated.

 

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 and Orange locations are ISO 13485:2016 certified.

Our Providence office 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.

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).
  • 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.

Need an expert opinion?

Contact one of our experts to accelerate your innovation today.