Medical Devices and IVDs

Post Market & Vigilance

Post Market Surveillance (PMS) and Vigilance are crucial aspects of regulatory oversight in the medical device and pharmaceutical industries. They involve monitoring the safety and performance of products after they have been placed on the market to identify and respond to any adverse events or issues that may arise.

Post Market Surveillance Medical Device

Post Market Surveillance refers to the systematic process of monitoring the performance and safety of medical devices or pharmaceutical products once they are available to patients and healthcare providers.

Detect and assess adverse events or issues related to product safety or performance.
Evaluate effectiveness of risk mitigation measures implemented during pre-market stages.
Collect data for ongoing product improvement and regulatory compliance.
Collect and analyze data from complaints, adverse event reports, clinical studies, and registries.
Conduct trend analysis to identify patterns or emerging issues.
Implement corrective and preventive actions (CAPAs) to ensure safety and effectiveness.

Vigilance

Vigilance is the process of monitoring and reporting adverse events associated with medical devices or pharmaceutical products to regulatory authorities. It involves timely collection, assessment, and reporting of adverse events to ensure patient safety.

Prompt reporting of adverse events by manufacturers, healthcare professionals, and patients.
Assessment of reported events to determine causality, severity, and impact on patient safety.
Communication of safety information and regulatory actions to stakeholders.
Collaboration with authorities and stakeholders to implement necessary safety measures.

Other Important Terms

MIR (Manufacturer Incident Report): A report submitted by the manufacturer to regulatory authorities when a serious incident involving a medical device occurs.

FSCA (Field Safety Corrective Action): An action taken by the manufacturer to reduce a risk of death or serious health damage associated with the use of a medical device. It may include product recalls, design changes, or other corrective measures.

SAE (Serious Adverse Event): A serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or causes significant disability.

PSR (Periodic Safety Report): A comprehensive report submitted by the marketing authorization holder for pharmaceuticals, summarizing the safety profile of the product at defined intervals.

PSUR (Periodic Safety Update Report): Similar to PSR but specific to medical devices, providing updates on the safety and performance of the device at predefined intervals.

Advancing Healthcare Through Innovation

How OMC Medical Can Help Your Organisation with PMS and Vigilance?

Global Compliance Expertise: We offer comprehensive knowledge of post-market surveillance requirements across various regions, ensuring clients remain compliant with international regulatory standards.
Vigilance Strategy Development: We collaborate with clients to develop robust PMS strategies tailored to specific products and markets.
Adverse Event Reporting Guidance: OMC provides guidance on adverse event reporting processes, ensuring timely and accurate submissions to authorities worldwide.
Trend Analysis and Risk Assessment: We conduct detailed trend analysis and risk assessments to identify safety issues and mitigate risks.
Complaint Handling Support: OMC Medical assists in establishing effective complaint-handling procedures including investigation, documentation, and resolution.
Regulatory Liaison Services: OMC acts as a liaison between clients and regulatory agencies, ensuring smooth communication and global compliance.
Continuous Monitoring and Updates: We stay updated on regulatory changes and provide clients timely insights and recommended actions.
Training and Education: We offer PMS and Vigilance training programs to build internal competency and ensure compliance.
Audits and Inspections Preparation: We assist clients in preparing for PMS audits and inspections, ensuring readiness and full compliance.
Continuous Improvement Initiatives: OMC supports clients in implementing continuous improvement strategies to enhance PMS processes and drive product quality and safety.

Benefits of Choosing Our Services

Regulatory Confidence

Stay ahead of evolving regulations with expert guidance. Minimize the risk of non-compliance, regulatory penalties, and product recalls.

Enhanced Product Safety & Performance

Continuous monitoring ensures potential risks are detected early. Data-driven insights improve product quality and patient safety.

Time & Cost Efficiency

Avoid delays and costly compliance mistakes with our streamlined processes. Focus on innovation while we handle your regulatory needs.

Improved Market Access & Reputation

Compliance with PMS and vigilance requirements increases trust among regulatory bodies, healthcare professionals, and end-users. Strong safety records enhance brand credibility and product acceptance.

Dedicated Support & Training

Personalized consultations to meet your specific PMS and vigilance requirements. Comprehensive training programs to keep your team updated on regulatory best practices.