Medical Device Services
Post-Market Surveillance
Post-Market Surveillance (PMS) is a critical aspect of the lifecycle management of medical devices (MDs) and in vitro diagnostics (IVDRs). It refers to the systematic process of collecting, analyzing, and interpreting data related to the safety and performance of these devices once they are on the market, in order to identify any adverse events or potential risks associated with the use of these devices, thereby ensuring patient safety and device efficacy.
It is a legal obligation for manufacturers under the European Union’s Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR).
Post-Market Surveillance System
A Post-Market Surveillance System is a structured and systematic process implemented by manufacturers to actively and continuously gather, record, and analyze relevant data on the quality, performance, and safety of a medical device throughout its entire lifecycle.
This system is a legal requirement under the EU MDR and IVDR, and it is crucial for identifying and investigating potential safety risks, ensuring the ongoing effectiveness of the device, and facilitating necessary improvements.
Post-Market Surveillance Plan
Biocodex PhaMe is here to support manufacturers in developing and maintaining an effective Post-Market Surveillance System.
We assist in choosing the appropriate data sources and strategies for monitoring the safety of your medical device, ensuring that all relevant information is captured and analyzed effectively.
Our team of experts will work closely with you to create a comprehensive Post-Market Surveillance Plan that aligns with your specific needs and regulatory obligations. We ensure that your system is in compliance with the ISO standards and EU regulations, providing you with peace of mind and allowing you to focus on your core business.
Data Collection
Data Collection is the backbone of an effective Post-Market Surveillance (PMS) system.
At Biococex PhaMe, we understand that every manufacturer’s needs are unique. Therefore, we offer a tailored service that allows manufacturers to outsource their data collection process, including complaint management, to us. Whether you need to outsource the entire process or specific sections such as literature monitoring, we’ve got you covered.
We take on the responsibility of choosing and monitoring the appropriate data sources, ensuring that all relevant information is captured and analyzed effectively.
Complaint Management
Complaint Management is a key component of reactive post-market surveillance as it provides direct input from users about the performance and safety of the device.
Biocodex PhaMe offers manufacturers the option to outsource their complaint handling process to us. We record and classify the complaints, recognize feedback relevant to PMS, and process it accordingly.
Post-Market Clinical Follow-up
Post-Market Clinical Follow-up are sources that provide additional, often broader, information about the safety and performance of the device in the real world.
We assist manufacturers in choosing the appropriate sources and actively monitoring them.
- Examples of possible sources to monitor include:
- Scientific literature
- Regulatory authority databases on incidents and field safety notices
- Regulatory authority publications
- Medical device registries
- Digital media
- Post-Market Clinical Follow-up studies
Materiovigilance
Materiovigilance, also known as Medical Device Vigilance, involves the continuous monitoring and evaluation of Incidents related to the use of medical devices.
At Biocodex PhaMe, we process vigilance information, recognize incidents that require reporting to regulatory authorities, determine if Field Safety Corrective Actions are required, and send appropriate reports to authorities. This comprehensive service ensures that all incidents are handled promptly and effectively, allowing manufacturers to maintain the highest standards of safety and compliance.
Incident Management
At Biocodex PhaMe, we offer a comprehensive Incident Management service. Our team of experts is adept at classifying, processing, and recording vigilance information directly into the client’s quality.
Field Safety Corrective Actions (FSCAs)
We guide manufacturers through the process of implementing a Field Safety Corrective action (FSCA), ensuring that all actions taken are in line with regulatory requirements and are effectively communicated to all relevant parties. This helps manufacturers maintain the highest standards of patient safety and regulatory compliance.
Authority Reporting
We can help our clients with incident reporting and trend reporting. Field Safety Notices (FSNs).
Signal & Benefit-Risk Management
Periodic Safety Update Reports (PSURs)
Legislation Monitoring
We provide legislation monitoring on EU-level and locally in the Nordic and Baltic countries. The legislation monitoring service ensures compliance with regulations, guidelines and procedures.
Regular monitoring is performed in national competent authority websites in the Nordic and Baltic countries, as well as monitoring on EU-level. Relevant updates are reviewed, analyzed, and informed to clients promptly. Our goal is to help navigate potential legislative updates and we can support with translations of local requirements to ensure compliance.