Life Cycle Management & Post Market Surveillance
Ensure safety and compliance throughout your product’s journey. From design to post-market data, we help you monitor performance, manage risks, and drive continuous improvement.
Our experts will support you to plan and document how you should ensure the safety and effectiveness of medical devices/IVD’s through continuous monitoring and data analysis. Post-market surveillance helps identify issues, improve products, and enhance patient safety. It is crucial for maintaining safe and efficient products throughout the entire product life cycle.
Life Cycle Management
Life Cycle Management (LCM) is an essential end-to-end framework that extends from the earliest concept of a medical device or IVD, through its design, manufacturing, commercialization, and all the way to its eventual retirement from the market. Proper LCM ensures that every phase of a product’s existence is governed by robust risk management, regulatory compliance, and a proactive approach to quality improvement.
Our approach to LCM integrates regulatory strategy, technical documentation, product change control, and continuous improvement initiatives, so you can adapt quickly to shifting regulatory landscapes and emerging market demands.
Post Market Surveillance
Post Market Surveillance (PMS) is a cornerstone of life cycle management. Far beyond a regulatory obligation, PMS is a dynamic, ongoing process that systematically gathers and analyzes data about your product’s performance in real-world settings after it reaches the market. This includes monitoring for adverse events, trends in complaints, user feedback, and relevant scientific literature.
The goal is early detection of potential safety or performance issues as well as opportunities for product enhancement. Effective PMS helps you not only to comply with regulatory requirements (such as MDR/IVDR) but also to demonstrate to notified bodies and competent authorities that your devices remain safe and effective for patients and end-users.
A comprehensive PMS system encompasses several key activities:
- Data Collection: Gathering information from a variety of post-market sources, such as incident reports, customer complaints, published studies, and registry data.
- Trend Analysis: Using statistical methods to detect patterns, identify emerging risks, and recognize areas where product improvements are needed.
- Risk Assessment: Continuously evaluating the benefit-risk profile of your device in light of new data, and documenting these findings in your risk management files.
- Corrective and Preventive Actions (CAPA): Initiating targeted actions to address identified issues, prevent recurrence, and enhance product safety and performance.
- Regulatory Reporting: Fulfilling obligations for vigilance reporting, including timely notification of serious incidents and field safety corrective actions to the authorities.
- Post-Market Clinical Follow-up (PMCF): Conducting ongoing clinical studies or gathering clinical data to confirm the safety and performance of your device over time, as required by MDR and IVDR.
Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF)
What is PMCF/PMPF?
The EU MDR and IVDR regulations require a system of continuous post-market surveillance to ensure that medical devices and in vitro diagnostic devices continue to function as intended and are safe throughout their lifetime after they have been placed on the market.
- Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF) are critical components of the PMS) system:
- PMCF gathers real-world clinical data to confirm the safety and performance of medical devices.
- PMPF applies to IVDs and ensures ongoing performance evaluation through scientific data collection and analysis.
Navigating the complexities of PMCF and PMPF can be challenging, but that’s where we come in. We offer clear, compliant, and efficient solutions that help you plan, execute, and document your post-market activities with confidence.
Our PMCF/PMPF services – End-to end-support:
- Strategic Planning: Tailored PMCF/PMPF plans aligned with regulatory expectations.
- Study Design: Support with surveys, real-world data collection, and Clinical investigations
- Data Analysis & Reporting: Comprehensive evaluation and documentation for regulatory submissions.
- Regulatory Compliance: Ensuring your documentation meets MDR/IVDR requirements.
- Gap Analysis & Remediation: Identifying and addressing compliance gaps in your current processes.