To determine the relevant keywords for the search, we build a ‘research question’, together with your team, following a recognized method. After your approval, we conduct a systematic literature search. We select, appraise and extract the data. The deliverable is an unbiased Literature Search Report, to provide answers to the ‘research question’. Although you could use the report for different purposes, it will certainly serve as input for pre- and post-market activities.
We collect and assess clinical datasets and write clinical evaluation reports (CERs)
Following the requirements of the MDR and the guidance of the MEDDEV 2.7/1 revision 4
Confirmation of conformity with relevant general safety and performance requirements of Annex I of the MDR, goes through planning, conducting and documenting a clinical evaluation in accordance with the MDR requirements. The research and scientific background of our team allows us to perform this work, with the input of your device experts.
We lead and oversee the risk management process
Following EN ISO 14971 and IEC 62366-1
Risk management is a multidisciplinary exercise. It requires knowledge of the product design characteristics, manufacturing process, intended use, claims, mode of action as well as a deep understanding of the application of standards EN ISO 14971 and IEC 62366-1 which provides the rules for the risk management process including usability risk management. We have an extensive experience in risk assessments and we use dedicated tools which support systematic analysis, assessment and process compliance. We excel in coordinating risk management processes and in writing and organizing the resulting documentation in a way that ensures traceability to product, usability, general safety and performance requirements and specifications.
We write the Biological Evaluation Report
We support the legal manufacturer of the device with the planning of the device biological safety assessment and the writing of an objective and compliant report.
When seeking CE marking for a medical device that is intended to contact the body, directly or indirectly, the legal manufacturer must demonstrate that the device is biocompatible, for the specific application. The Biological Evaluation Report is the document required to demonstrate the device biocompatibility, regardless of its classification.
Part I of the standard EN ISO 10993 provides a framework, a systematic approach to plan a biological evaluation (evaluation and testing) within a risk management process. Concisely, the systematic biological evaluation of medical devices involves the determination of the nature of body contact, the precise identification of the materials used in the device and the materials used during the manufacturing of the device, an assessment of the impact of the manufacturing process on the device biological safety characteristics, the evaluation of the existing clinically relevant (biocompatibility) data of these materials and as deemed necessary, if the data is non-existent or insufficient, the biocompatibility testing of the device.
Following the standard (EN ISO 10993-1) BioTop Medical supports the legal manufacturer of the device with the planning of the device biological safety assessment and the writing of an objective and compliant report.
We prepare your technical documentation
The technical documentation (TD) of a medical device shall be such as to allow the conformity of the device with the requirements of the medical device regulation to be assessed. Although the MDR describes the specific elements required in the TD, its preparation can be quite overwhelming. BioTop Medical can help you with writing the documents and assembling the TD.