A small medical device company facing limited resources successfully updated their QMS and achieved MDR compliance with AlvaMed’s expert guidance and efficient tools.
Producing clinical evaluation reports (CERs) for medical devices can be a complex and challenging process, involving these major hurdles:
AlvaMed has experience with CERs, particularly with respect to EU MDR compliance. We know what notified bodies are expecting, and we will prepare your team and documentation accordingly.
Determine device classification per EU MDR requirements.
Thorough review of the data on your product, from internal pre- and/or post-market clinical studies and those conducted outside of your organization.
Creation of an MDR-compliant Clinical Evaluation Plan, which will guide the completion of the process.
Plan, execute and report on relevant peer-reviewed literature on subject matter.
Execute an MDR-compliant CER derived from the Clinical Evaluation Plan.
Create or update PMCF Plan based on perceived areas of needs based on the findings of the Clinical Evaluation.
A small medical device company facing limited resources successfully updated their QMS and achieved MDR compliance with AlvaMed’s expert guidance and efficient tools.
CASE STUDY
Read this case study to discover how AlvaMed helped a client navigate the complex EU MDR and provided expert clinical evaluation support.
CASE STUDY
AlvaMed’s approach to training sets us apart from competitors. Our training is customized to the client’s needs and delivered by regulatory, quality and clinical consultants.
AlvaMed is a great partner for a small company like ours. Their invaluable support, including quality assurance consulting services at various levels in the organization have supported our Director of QA/RA without the need to hire additional people. Their expertise in bringing companies into compliance with the EU MDR and supporting notified body audits, has been vital in helping us navigate the complexities of our industry. We highly recommend AlvaMed to any company looking for a reliable and supportive partner.
Endosurgical Device Company
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
The length of the project is dependent on multiple areas, including Device Classification; New/Legacy Approval; Amount of Clinical Study Data; Number of Peer-reviewed literature articles to review and number of safety incidents. Reach out to us directly, to have a conversation about your specific product needs.
Certain products will require a level of clinical study evidence, such as Class III and implantable devices.
Robust safety and performance data from high-quality clinical studies, covering each device indication, is the benchmark.
Kerry has assembled CERs across a wide spectrum of medical device indications, for small one product clients up to large multi-national clients with an array of clinical products. A thorough researcher, she is able to understand the intricacies of your products clinical background, in order to assemble the most complete documentation of its’ clinical results. She then uses her extensive experience in successfully distilling this information into the CER to support the interactions with your notified body to bring you into compliance with current MDR standards.
