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

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