Expert services for medical devices and IVDs – from clinical investigations to regulatory compliance and post-market activities
The development, registration and maintenance of medical devices and in vitro diagnostics (IVDs) requires thorough regulatory and documentation expertise. Medfiles can support you throughout the product lifecycle – from clinical investigations to regulatory compliance and post-market activities. Our services are flexible: we can assist with specific tasks or act as a long-term partner.
Regulatory services for medical devices and IVDs
We can help you ensure that your medical device or IVD complies with the applicable EU regulations (MDR and IVDR). Our services include device classification, risk class determination, conformity assessment, preparation of technical documentation, CE marking procedures and communication with notified bodies and authorities. For products already on the market, we can manage your ongoing regulatory obligations on your behalf.
Clinical investigations and performance evaluations for medical devices and ivds
We support medical device and IVD studies from study design, through regulatory and ethical approval, to conduct, monitoring and reporting. We help manage local and multinational studies.
Our services include study documentation, monitoring, data management, statistical analysis and final reporting. Our extensive experience in MDR and IVDR studies and our competent team ensure a smooth study process. Drug-device combination studies are part of our service offering.
Post-market and Vigilance services for medical devices and IVDs
We support your vigilance activities both during clinical investigations and after your product is on the market. Medfiles ensures that safety data is collected and processed in a structured and compliant manner in accordance with MDR and IVDR requirements.
Our services include the preparation of PMS and PMCF plans, adverse event assessment and reporting, signal detection, trend reporting and safety alert monitoring. We also support safety management during clinical investigations, including preparation of safety plans, SADE/USADE reports and DSURs.
Whether you need assistance with a specific task or a long-term partnership throughout the device lifecycle, our team is here to help. Medfiles offers a wide range of services for devices marketed in the EU and beyond.
Free webinar: Medical device clinical evaluation
In this webinar you will learn if your medical device is in a need of clinical investigations. You will also learn about properly documenting a clinical evaluation, including how to compile a clinical evaluation plan and a clinical evaluation report according to the requirements in the MDR. In the webinar we will also give practical tips for ensuring that your clinical investigation meets the needed GCP requirements and none of the essential elements are forgotten.
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