Medical Device Qualified Supplier Directory
Regulatory Compliance Associates Inc. Company Profile
Qualifications: ISO 9001, Supplier to Medical Manufacturers
Markets Supplied: Worldwide
Regulatory Compliance Associates Inc. (RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device. Our team has navigated the front lines in Quality, Regulatory Affairs, Operations, Manufacturing and R&D. RCA provides a broad spectrum of quality, regulatory and compliance services to assist global companies with obtaining product clearance and/or approval in the US, US Agent Services, Compliance with US FDA Quality System Regulations (QSR), ISO 13485 and Auditing. We also provide support with RA/QA Outsourcing, FDA Inspection Readiness including 483/Warning Letter/Consent Decree Remediation, and Global Product Submissions and Registration.
Specialties: Quality Systems & Quality System Remediation, Regulatory Affairs, Global Product Submission & Registration, Product Development, Supplier Quality Audits, RA/QA Outsourcing, US Agent Services, US FDA Market Clearance/Approval, and Risk Management