Sub Services
Adverse Event Reporting
Systematically collecting and analyzing data on adverse events associated with medical products. Ensuring timely reporting to regulatory authorities in accordance with local and international requirements.
Real-World Evidence (RWE) Collection
Gathering data from real-world use of medical products to assess their performance, effectiveness, and long-term impact. Utilizing RWE to inform clinical decision-making and improve product lifecycle management.
Risk Management and Mitigation
Identifying potential risks associated with medical products and implementing strategies to mitigate these risks. Conducting risk assessments and developing robust risk management plans to ensure patient safety.
Regulatory Compliance and Documentation
Ensuring that all PMS activities comply with regulatory standards such as the EU Medical Device Regulation (MDR) and the FDA’s guidelines. Managing documentation and audits to maintain transparency and accountability.
Data Analysis and Reporting
Employing advanced data analytics to interpret PMS data, identify trends, and generate actionable insights. Providing comprehensive reports to stakeholders, highlighting key findings and recommendations.
Customer Feedback and Complaint Handling
Implementing systems to capture and analyze customer feedback and complaints related to medical products. Using this information to improve product quality and address any issues promptly.
Training and Support for PMS Processes
Offering training programs for clinical teams on PMS processes, tools, and technologies. Providing ongoing support to ensure effective implementation and management of PMS activities.
Continuous Improvement Initiatives
Leveraging PMS data to drive continuous improvement in product design, manufacturing, and distribution. Collaborating with clients to enhance their product offerings based on surveillance findings.