Complaint Handling & PMS

Complaint Handling & Post-Market Surveillance

We help medical device companies build and maintain compliant, effective complaint handling and post-market surveillance systems that meet FDA, ISO 13485, and EU MDR requirements — transforming real-world product data into actionable quality and safety intelligence.

What We Offer

Complaint Handling

• Complaint System Design & Implementation — We design complaint handling procedures and workflows that meet the requirements of 21 CFR Part 820.198 and ISO 13485, ensuring complaints are captured, evaluated, investigated, and closed in a consistent, audit-ready manner.
• Complaint Intake & Triage — We establish clear criteria for what constitutes a complaint, how to distinguish complaints from general inquiries, and how to prioritize investigations based on severity and regulatory reportability.
• MDR & Vigilance Reportability Determination — We evaluate complaints for Medical Device Report (MDR) reportability under 21 CFR Part 803 and EU Vigilance reporting obligations, ensuring timely and accurate submissions to regulatory authorities.
• Complaint Investigation Support — We conduct or facilitate thorough complaint investigations, including root cause analysis, trend evaluation, and documentation that satisfies both internal quality standards and external regulatory expectations.
• Complaint Backlog Remediation — We triage and close aged complaint records, restoring compliance and reducing regulatory risk in advance of audits or inspections.

Post-Market Surveillance (PMS)

• PMS Plan Development — We develop proactive, risk-based PMS plans aligned with ISO 13485, EU MDR Article 83–86, and FDA post-market expectations — defining data sources, collection methods, evaluation frequency, and reporting outputs.
• Post-Market Surveillance Reports (PMSR) & PSURs — We author Post-Market Surveillance Reports and Periodic Safety Update Reports (PSURs) required under EU MDR, synthesizing complaint data, literature, registry data, and field performance into a comprehensive safety narrative.
• Post-Market Clinical Follow-Up (PMCF) — We support the design and execution of PMCF plans and reports that demonstrate ongoing clinical performance and safety for EU MDR compliance.
• Trend Analysis & Signal Detection — We analyze complaint, service, and field data to identify emerging trends and safety signals — enabling proactive risk management before issues escalate to recalls or regulatory action.
• Field Safety Corrective Action (FSCA) Support — We assist in evaluating the need for field safety corrective actions and recalls, and support the planning, execution, and regulatory notification process.
• PMS & QMS Integration — We connect your post-market surveillance outputs to your risk management file, CAPA system, and design controls — creating a closed-loop quality system that continuously improves product safety and performance.

Why It Matters

Complaint handling and post-market surveillance are among the most frequently cited areas in FDA inspections and EU MDR Notified Body audits. Beyond regulatory compliance, a well-functioning PMS system is your earliest warning system for product safety issues — protecting patients, reducing liability, and preserving your brand. Under EU MDR, PMS requirements are significantly more rigorous than under the previous MDD, making expert support more important than ever.

Who We Serve

We partner with medical device manufacturers at every stage — from companies building their first complaint handling system to established organizations remediating PMS gaps ahead of EU MDR technical file reviews or FDA inspections.