Building a Quality Clinical Evaluation Report
MEDDEV 2.7.1 Rev 4 dictates new requirements for generating clinical evaluation reports (CER) properly. In this white paper, we explain the Rev 4 requirements in simple and concise terms. Regulators have shifted their focus on the quality of clinical evaluations with deeper scrutiny on the equivalence or predicate devices, selection of literature for review, patient sample in the literature, qualification of the evaluators, etc. There are many reasons behind these changes including recent adverse events in the market, responsibility to provide safe and effective medical devices and result of the work of GHTF to have global harmonized standards. We provide a case study to as an example of developing a clinical evaluation report on a Class IIb Implant. We hope that this paper provides you with the tools affective and accurate CER’s for your products.
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CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”