Post-Market Surveillance (PMS) Reporting Support for Medical Devices
In today’s fast-evolving medical device industry, regulatory compliance goes hand-in-hand with patient safety and product quality. International Associates Limited offers expert Post-Market Surveillance (PMS) Reporting Support, helping manufacturers meet the rigorous requirements of ISO 13485:2016, UK MDR, EU MDR, and FDA QSR.
Our PMS support service ensures your medical devices remain compliant throughout their lifecycle, providing systematic monitoring, data analysis, and reporting to regulatory authorities. By partnering with us, you can proactively identify potential risks, maintain regulatory readiness, and safeguard both patients and your business reputation across global markets.
WHY IS PMS CRITICAL FOR YOUR BUSINESS?
- Drive Improvement: Use real-world data to enhance device design and functionality.
- Stay Compliant: Regular PMS reports are vital for ongoing compliance with regulatory requirements.
- Ensure Safety: Continuously monitor the safety and efficacy of your devices to protect users.
DIVING DEEPER: OUR PMS REPORTING SERVICE EXPLAINED
Post-market surveillance is a regulatory requirement that cannot be overlooked. It involves detailed monitoring of a medical device’s performance after it has been released to the market. The goal is promptly identifying and addressing potential safety issues, ensuring that all devices continue performing as intended and adhere to safety norms.
WHAT WE OFFER
- Tailored PMS Plans: Not sure where to start? We’ll help you develop a PMS plan that fits your devices and business’s needs, ensuring all regulatory bases are covered.
- Detailed PMS Reports: Our team of experts will gather and analyse data from various sources, including Field Safety Notices, corrective actions, and the latest clinical literature. We provide comprehensive reports that not only meet but anticipate regulatory scrutiny.
- Recommendations: Your report will also include several recommendations on elements in the QMS and/or technical documentation that you may need to consider.
COMPREHENSIVE INPUTS CONSIDERED
- Field Safety Notices (FSNs)
- Field Safety Corrective Actions (FSCAs)
- New clinical literature
- Material reports
- Safety bulletins from competent authorities