The Validant Group of companies has united under a single, cohesive brand: ELIQUENT Life Sciences. Validant is proud to join this unprecedented assembly of regulatory experts as we redefine regulatory excellence from thought to finish. Together, we clear the way to better health. Learn More.

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Medical Device Consulting Services

As innovation in the medical device field accelerates, it is essential to have a robust product development and commercialization strategy that is compliant, practical, and drives continuous product quality. Why Validant?

medical device consulting services

Lifecycle Support from a Single Partner

Validant offers end-to-end strategy, execution, and support services to bring Class I, II, and III medical devices to market and ensure their safe, reliable access. This includes:

  • Regulatory Strategy
  • Agency Submissions
  • Inspection Readiness & Support
  • Registrations & Listings
  • Quality Management System
  • GMP & Compliance
  • Post-Market Surveillance
  • Health Authority Enforcement Action Response & Remediation
medical device end to end consulting

Optimize Quality Management & Compliance

Expert in the nuanced regulations that apply to medical device developers and manufacturers, Validant provides hands-on support and guidance to help you navigate:

  • Agency Submissions: 510(k), PMA, De Novo
  • Pre-Submissions: IDE, HDE, HUD, Master Files
  • ISO 13485
  • ISO 14971
  • 21 CFR Part 820
  • EU MDR / IVDR

How can we
help you?

Tell us what you’re looking to achieve.
We’ll put our experience to work on your specific problem.

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Introducing ELIQUENT Life Sciences

The Validant Group of companies has united under a single, cohesive brand: ELIQUENT Life Sciences. Together, we are redefining regulatory excellence and clearing the way to better health.

Learn More
Visit Eliquent.com
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