Risk management in the medtech industry extends beyond product development and manufacturing to become an integral part of your product’s life cycle. Clin-r+ looks at how ISO 14971:2019 specifies the international requirements for medical device risk management systems, as well as best practices for the device’s entire life cycle.
Plan for success: IVD Performance Evaluation Process Planning and Report (PER). Due to EU IVDR 2017/746 new requirements are being imposed on IVD manufacturers pursuing CE marking for their devices. Clin-r+ provides insight and guidance in this document.
A Clinical Evaluation Assessment Report is required for all manufacturers who want to sell medical devices in the European Union. CEAR demonstrates that your product accomplishes its intended purpose without endangering users or patients, and the manufacturer’s reputation or financial prospects.
Post Market Surveillance is a collection of processes and activities used to monitor the performance of a medical device. Clin-r+ identifies what your Notified Body wants to see in the Post Market Surveillance Plan and PSUR/PMSR.
Performing effective literature searches for EU MDR and other regulations: Overall, the literature search must be exceedingly thorough, consistent, and cover a wide range of search parameters. CLIN-r+ looks at what’s effective.
Clin-r+ shares how the QMS underpins this process, how the PMS process sits within this, and divides Post Market Surveillance between reactive and proactive PMS.
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