Regulatory Compliance and Risk Management for Combination Product Manufacturer

QSN assisted a leading global combination product manufacturer in strengthening regulatory compliance and risk management by addressing documentation gaps, enhancing change management processes, and ensuring alignment with EU MDR, ISO 13485, and ISO 14971 standards.

Company Profile

• A leading global manufacturer of combination products with a strong presence in the pharmaceutical and medical device sectors.
• Specializes in developing innovative drug-delivery systems.
• Operations spanning multiple countries, requiring compliance with diverse regulatory frameworks, including EU MDR, ISO 13485:2016, and ICH guidelines.

Business Situation

The manufacturer faced challenges in aligning its design history files (DHF) and risk management documentation with the latest regulatory requirements. With increasing scrutiny from global regulatory agencies and evolving compliance expectations, the company needed to enhance its processes to meet EU MDR and ISO 14971 standards, and sought to improve change management and risk assessment methodologies to ensure product safety and compliance.

Technical Situation

A detailed assessment of the company’s systems identified several operational deficiencies that required remediation. The design history files (DHF) contained documentation gaps that required independent reviews and verification. Risk management activities, including hazard analysis and failure mode assessments, were outdated and did not fully align with evolving regulatory expectations. Additionally, change assessments lacked a structured framework, leading to inconsistencies in managing product modifications at the site level, particularly in materials, suppliers, and packaging. Stability and shelf-life testing also required stronger oversight to ensure long-term product integrity. Finally, a global labeling change project became necessary following an increase in customer complaints, requiring updates to Instructions for Use (IFUs) and Patient Information Leaflets (PILs) within the CAPA system.

Solution

QSN was engaged to implement a structured regulatory compliance and risk management framework. To address the gaps in DHFs, independent reviews and data verification were conducted to ensure compliance with EU MDR and ISO 13485:2016. QSN led design reviews for lifecycle management changes, ensuring regulatory alignment while enhancing risk management documentation through structured updates to risk management plans, hazard analysis, dFMEAs, pFMEAs, uFMEAs, risk management summary reports, risk-benefit analyses, and medical rationale documents.

What set QSN apart was our proactive risk management approach, integrating a proactive compliance model that allowed the client to anticipate and mitigate regulatory risks before they became audit findings.

Benefits

Through QSN’s structured approach, the manufacturer achieved significant regulatory and operational improvements. Compliance with EU MDR, ISO 13485, and ISO 14971 was enhanced, reducing regulatory exposure and strengthening product safety. Risk management practices were significantly improved, leading to more effective identification and mitigation of potential hazards. The change-management process was streamlined, increasing efficiency and minimizing delays in product modifications. Improved documentation and verification of design history files ensured audit readiness and regulatory compliance. The successful execution of the global labeling change project mitigated compliance risks associated with customer complaints, while the remediation efforts for stability and shelf-life testing reduced long-term product sustainability concerns.

QSN’s expertise in regulatory compliance and risk management provided the client with a structured roadmap to maintain compliance, enhance product safety, and streamline change management processes, ensuring ongoing success in the global market. If you require our support or have any questions about how we can address your pain points, please feel free to reach out to us at info@qualitysolutionsnow.com.