Post-Market Surveillance for Medical Devices

Ensure patient safety, regulatory compliance, and market confidence with expert PMS practitioners from TSQE. Medical devices manufacturers are mandated by various regulations to use a methodical process called post-market surveillance (PMS) to monitor the effectiveness, quality, and safety of medical devices after they are put on the market. To determine whether any action, such as corrective or preventive measures, is necessary, or to notify the authorities or the notified body, PMS uses real-world data from product use. In important markets like the US and the EU, PMS is mandated by laws. PMS is an essential tool for ensuring that medical devices remain safe and effective, as well as for identifying areas where the device can be improved.

To learn about PMS, see our detailed blog: Explaining Post-Market Surveillance (PMS) for Medical Devices From the blogs section of TS Q & E

For medical device businesses seeking peace of mind in the EU MDR era, TSQE offers comprehensive post-market surveillance (PMS) services backed by unparalleled expertise.

Benefits of TSQE’s PMS Services

• Enhance patient safety: Promptly identify and address any dangers associated with medical devices.

Enhance regulatory compliance: Maintain a competitive edge by proactively conducting continuous risk assessments and remaining vigilant to meet the standards of MDR/IVDR.

• Boost market confidence: Establish trust and guarantee the marketability of products with robust safety and performance data.

Enhance product development: Use PMS data to optimize future iterations of the medical devices and associated gadget.

• Minimize expenses: Implementing proactive risk management helps prevent expensive recalls and remedial measures.

Let TSQE be your trusted partner in navigating the post-market landscape. Contact us today for a free consultation and see how our expert PMS services can safeguard your success.

Why Choose TSQE for Your PMS Needs?

• Unmatched Expertise: Our staff has several decades of experience navigating the complexities of EU laws, including MDR/IVDR. Dr. Gianluca Tordi, a recognized specialist in medical device compliance, leads our team.

• Holistic Approach: We go above and above by providing a comprehensive range of PMS services, including trend tracking, product risk assessment, adverse event reporting, and data analysis.

• Customized Solutions: We adjust our strategy to your particular device and market, providing all-inclusive PMS programs that satisfy your particular demands and legal requirements.

• Simplified Procedures: To guarantee effective and dependable data gathering, analysis, and reporting, we make use of state-of-the-art technology and tried-and-true techniques.

• Proactive Partnership: Together, we go beyond simple observation. We serve as your trusted advisor, keeping you updated at every stage and assisting you in foreseeing and resolving any obstacles.

Interact with our Experts on PMS

It is always recommended to have a call with us and let us know your challenges and how we can help in that., there are always two options available:

  • Schedule a call with our experts to discuss your specific needs and challenges.
  • Request a quote for customized PMS solutions tailored to your device and market.
Posted in: