Resources

Whether struggling with a submission strategy and execution or dealing with regulatory compliance, RCA stands ready to support your medical device needs. Our consultants have years of experience as regulatory...

Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and/or maintaining a robust and comprehensive global Quality Management System (QMS).

Regulatory Compliance Associates® (RCA) MDR consulting service offerings to Assist Existing/New Clients with Implementation of the EU MDR requirements. Perform a Comprehensive Review of Client’s Entire Product Portfolio: Confirm whether...

From Launch to Lifecycle, RCA can support your Design History File We offer expertise in helping you navigate through new product development and remediating legacy Design History File (DHF) files...

Outsourcing has become an increasingly common practice in the life science industry, and more companies are turning to outsourcing to manage operations and tactical skills, and also help adopt best...

Regulatory audits and compliance assessments are essential in identifying product, process and system deficiencies, risk assessment, and inspection readiness. Our FDA veterans and industry consultants use a risk-based approach to...