Medical Devices & Veterinary pharmacovigilance
"Enhancing safety and innovation in medical devices through compliance-driven strategies and expert regulatory support"
PMS system set-up
“Building a Robust Post-Marketing Surveillance Infrastructure.”
We customize the PMS system to address the unique safety monitoring needs of medical devices and veterinary medicines. Whether your product is a medical device or a veterinary drug, our team designs a system to collect, assess, and report safety and performance data in compliance with local and international regulations.
For medical devices, this includes device-related adverse events, malfunctions, and recalls; for veterinary products, it includes adverse reactions in animals and environmental concerns. Medical device Pharmacovigilance requirements vary between different medical device markets, i.e. EU requirements for post-market surveillance for medical devices differ significantly from that of the US.
At CliniResource, we can help manufacturers to develop an ideal targeted strategy based on the risk profile for EU and US market. CliniResource can help you developed Post-market surveillance plan and system that include customer complaints, Medical Device Vigilance Reporting, trend analysis reporting, analysis of serious incidents & field safety corrective actions based on US FDA and EU MDR. We can take care of your post-market need of writing and maintaining Clinical Evaluation Report (CERs), PMSR/PSUR and Summary of Safety and Clinical Performance (SSCP).
Incidents & Complaints Management
“Ensuring Safety, Compliance, and Customer Satisfaction.”
Incident and complaints management refers to the systematic process of handling, investigating, and resolving incidents (unexpected or undesirable events) and complaints (customer or user dissatisfaction) related to products or services. In regulated industries such as pharmaceuticals, medical devices, and healthcare, effective incident and complaints management is essential to ensure safety, product quality, and compliance with industry regulations.
Field Safety corrective actions management
“Ensuring Patient Safety and Regulatory
Compliance.”
Field Safety Corrective Actions (FSCA) refer to corrective actions taken by a company in response to safety concerns related to a product that has already been distributed or is in use by patients or customers. FSCA is particularly important in industries such as medical devices, pharmaceuticals, and consumer products, where safety issues may arise after market release.
The goal is to address potential risks to health and safety, including product recalls, safety notices, or device modifications, in accordance with regulatory requirements. Effective FSCA management ensures that safety issues are promptly identified, addressed, and communicated to the appropriate stakeholders (e.g., healthcare professionals, customers, regulators), and corrective actions are implemented to mitigate any potential risks.
Annual PMS report & PSURs
“Ensuring Safety, Compliance, and Continuous Monitoring.”
A comprehensive report submitted yearly to regulatory authorities, detailing the safety, performance, and post-market data on a medical device, including adverse events, malfunctions, or recalls. This report summarizes all safety-related activities and outcomes observed throughout the year.
Trend Analysis
“Spotting trends, enhancing safety”
Trend analysis in medical devices involves the systematic collection, evaluation, and interpretation of data over time to identify patterns or trends related to the performance, safety, and quality of a medical device. It is a proactive approach used to monitor the ongoing safety profile of a device and helps manufacturers detect potential issues before they become significant risks.
By analyzing historical data from post-market surveillance (PMS), adverse event reports, complaints, inspections, and clinical data, trend analysis enables manufacturers to assess product behavior, identify emerging risks, and improve product quality. This process is crucial for regulatory compliance and ensuring patient safety.
Setting Up Veterinary Pharmacovigilance system and compliances
“Ensuring safety and trust in veterinary pharmacovigilance”
Navigating the relatively uncharted territory of veterinary pharmacovigilance, our service addresses the unique challenges associated with adverse effects in animals and humans. Our team, well-versed in international guidelines for veterinary pharmacovigilance, specializes in situations where the regulatory landscape differs from human pharmacovigilance. We recognize the importance of gathering additional data on both animals and humans due to potential adverse reactions, acknowledging the limited exposure data given the constrained use of veterinary products.