Medical Devices

A medical device regulatory compliance consultant helps manufacturers meet applicable FDA and international regulatory requirements throughout the product lifecycle. Support may include quality management systems, design controls, risk management, regulatory submissions, internal audits, inspection readiness, and remediation. RCA works with medical device companies to identify compliance gaps and develop practical solutions that support product quality and regulatory success.

The FDA Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference and establishes requirements for medical device quality management systems. The regulation became effective on February 2, 2026. Manufacturers should evaluate their existing quality systems, documentation, procedures, and processes against applicable requirements and address identified gaps. RCA provides quality system assessments, implementation support, and remediation services to help medical device companies maintain compliance.

Medical device manufacturers should review quality system procedures and records, verify CAPA effectiveness, assess complaint handling and supplier controls, review design documentation, and train employees on inspection responsibilities. RCA offers inspection readiness consulting, mock inspections, audits, and gap assessments to help manufacturers identify vulnerabilities and strengthen their preparedness for regulatory scrutiny.

Remediation begins with understanding the deficiency, investigating its root cause, determining its broader impact, and implementing corrective and preventive actions. Companies should also evaluate whether corrective actions are effective and address related risks across the quality system. RCA supports medical device manufacturers with compliance assessments, quality system remediation, FDA response strategies, and implementation support.

Design controls are documented processes used to ensure medical devices meet defined user needs, intended uses, and design requirements. They include activities such as design planning, design inputs and outputs, reviews, verification, validation, transfer, and change management, as applicable. RCA helps medical device companies establish and improve design control processes, address design history file deficiencies, and integrate quality and regulatory considerations into product development.