Post-Market Surveillance (PMS) Report Support Service

• 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.

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.

• 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.

• Field Safety Notices (FSNs)
• Field Safety Corrective Actions (FSCAs)
• New clinical literature
• Material reports
• Safety bulletins from competent authorities

These inputs are crucial for ensuring device effectiveness throughout their lifecycle. By identifying trends, potential hazards, and areas for improvement, our PMS reports help you make informed decisions that enhance product safety and user satisfaction.