Your Clinical Evaluation Sherpa
Clinical Evaluation Plans & Reports Without the Headache
The EU Medical Device Regulation (MDR) has put a tremendous emphasis on clinical performance and benefit of new medical products along with maintenance of detailed post-market surveillance (PMS) data. The more general, lenient, & ‘once-and-done’ approach of clinical evaluations associated with the Medical Device Directive (MDD) are a thing of the past for companies that are transitioning to the MDR (or hope to in the future). Documenting the clinical performance of your product and the benefit which it provides to the patient is key to any successful European registration under the MDR. Gezellig Scientific has a team of clinical professionals that are dedicated to meeting our clients unique needs in performing clinical evaluations. Whether you are in need of a single clinical evaluation for a product, or need help establishing systems to support ongoing clinical evaluations and clinical data gathering - Gezellig has the expertise to provide bespoke support.
Our team of Clinicians, PhD Researchers, and Biomedical Engineers provides comprehensive support to all Clinical Evaluation needs.
Our Clinical Evaluation Approach
-
![Initiation Photo]()
01 - Initiation
Our expert biomedical and clinical teams will help you understand how the MDR regulations impact your medical device and how Clinical EvaluationPlans (CEP) and Clinical Evaluation Reports (CER) can set you up for regulatory and product success. We will provide a prompt quote with no hidden costs and a clear timeline so that you can hit your deadlines. At Gezellig, your burdens are our burdens and your timelines are our timelines.
-
![Device Review Photo]()
02 - Device Review
Our team will conduct a secure and confidential review of your technical files to identify and understand the devices classifications and the associated regulatory requirements. We review existing clinical evaluations and any Non-Conformity Reports (NCRs) to create the framework for clinical evaluation success.
-
![Literature Review Photo]()
03 - External Literature & Internal Data Review
Our team compiles and creates all relevant elements to meet requirements of MEDDEV2.7/a Rev 4, EU MDR, FDA, and Health Canada regulations.
Researchers develop questions and search terms for an exhaustive literature review.
Literature review writing with clear inclusion and exclusion criteria.
Develop an exhaustive State of the Art evaluation
Suggest sources for postmarked surveillance data and nonclinical data
Provide general suggestions and guidance
-
![Documentation Generation Photo]()
04 - Documentation Generation
Based on the outcome of the market review and literature search, our team of specialists compose needed documentation associated with the clinical evaluation plan (CEP) and associated report (CER) in conjunction with information which the client provides related to risk management actives and available post-market surveillance data. Once compiled, the documents are reviewed with the client, updated as necessary, and provided and a format which best suits the needs of your submission.
-
![Support Photo]()
05 - Continued Support
Gezellig is committed to providing support to achieve regulatory success. Whether that means working directly with reviewers to support the methodology employed or providing continued support to maintain the accuracy of clinical documentation and claims, we stand behind our work through its entire lifecycle.
