U.S. FDA Regulatory, Quality and Compliance Support
R&Q’s mission is to help patients get the devices they need by helping device and combination product companies get their safe and effective products to market. R&Q provides the full spectrum of Regulatory and Quality Assurance support, with large team of subject matter experts including former CDRH Scientific Reviewers. Go to RQTeam.com/Services to learn more.
- Regulatory - Complex regulatory strategies, pre-subs, 510(k)s, PMA’s, De Novo’s, EUA’s, and non-filing justifications, and general product development support for all classes and clinical specialties
- Quality Assurance - Design quality, safety risk management, post market surveillance
- Remediation - 483’s, warning letters, DHF remediation, strategic and tactical, scalable team
- Acquisition Integrations Support
- AND SO MUCH MORE!