Medical Device Vigilance Services

The post-marketing surveillance of medical devices is a practice that monitors the safety of medical devices after they are released into the market. The PMS requirements vary based on the medical device market, this is one of the reasons the medical device manufacturers should develop an individual strategy for different locations. A one-size-fits-all approach will not work for PMS as they vary based on region, for example, the US PMS requirements vary from the EU. In the EU, the devices are CE marked and also categorized into three different classes, the guidance and regulations will also vary based on the class of the device.

Medical device manufacturers need a strong comprehensive and proactive vigilance system to be in place to make sure that all the incidents are collected, captured, investigated, and if necessary reported to the local, national, and international requirements. In case the device is combined with an active pharmaceutical drug then it is highly important to make sure that the surveillance system meets the regulatory requirements of both the device component and drug where the MAH is also the device manufacturer.

Our Services

Vizen life sciences offer a complete set of medical device vigilance services for both post-registration needs and clinical studies. Our team of experts is well-versed in differentiating the requirements for non-marked CE, CE- marked devices, In Vitro Diagnostic Medical Devices, drug-device combinations, and Implantable medical devices guidance for both MEDDEV and European Union guidelines. We offer services such as

Project Management and Medical Device Consultancy
Global Safety Database and Safety Data Management
Case narratives and Medical assessment
Preparation of Device Vigilance Report and submission
Evaluation and ADE/MDI trending
Search and Review of Medical Literature
Medical Device Incident (MDI) case processing, Adverse Device Effect (ADE), coding, and follow-up
Status reporting and Monthly compliance
MDI and ADE reconciliation, SSCP
Periodic reporting ( DSURs, PSURs/PBRERs, PADERs, IND Safety Reports)
Post-Market Surveillance Reports (PMSR/PSUR)
Medical Device Risk Management
Vigilance Quality Assurance

Why Vizen Life Sciences?

Vizen life science has over a decade of experience in pharmacovigilance, we help our clients in developing a PMS strategy for their devices by leveraging our expertise. We also support the electronic reporting of medical devices using the 3500A. Apart from that we also report the preparation, execution, design, and submission of the PMS plans for both US and EU. We are also experienced in serious incident analysis, trend reporting, vigilance data analysis, field corrective actions, etc. Vizen will make sure that your vigilance reports are finished on time as per the regulations. We also help our clients in determining which incidents are reportable. Our experienced team of vigilance experts includes clinicians, case, and safety reviewers. Vizen’s team of experts is well experienced in providing 24X7 support to our clients.