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Technical Files for Medical Devices
- 1. Technical Files for MedicalDevices www.mavenprofserv.com
- 2. Content What is TechnicalFile? Medical Device Technical File (MDR) Consultant of Technical Files for Medical Devices Contact Us
- 3. What is TechnicalFile? The technical files for medical devices refer to all the documents that a medical device manufacturer has to submit to demonstrate that the product conforms to the applicable and current medical device regulations.
- 4. Technical files formedical devices shall include, e.g. a detailed description of the device and specification, reference to the previous and similar generation of the device, design information, pre-clinical testing information, clinical evaluation, and risk management of the medical device.
- 5. Technical files formedical devices shall be prepared by the medical device manufacturer and the information’s in the technical file or technical file for medical devices must be presented in a clear, organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the medical device in question.
- 6. Medical Device TechnicalFile (MDR) Want to prepare a medical device technical file as per the requirement of MDR 2017/745? If your answer is yes, you probably have lots of questions about the preparation of medical device technical files such as; What shall be covered in the medical devices technical file?
- 7. Which Annex of-MDR 745/2017 shall be referred for the preparation of medical device technical file according to MDR? Who will review and approve the medical device technical file? We at Maven Profcon Services LLP , shall give you all the answers. Medical device technical file shall be prepared as per the requirement of Annex II and Annex III of MDR 2017 / 745.
- 8. as per the Medicaldevice technical file shall be prepared requirement of Annex II and Annex III of MDR 2017 / 745. The technical file shall be submitted to the notified body or competent authority for review and approval for CE Certification. It should be made in the English language or the official language of an EU member state.
- 9. Under the MDR,the manufacturer shall safely store the technical documents for 10 years other than implantable device after the last device has been placed on the market, and in case of the implantable device, it should be safely stored for 15 years and non-EU manufacturer documents should be available with the Authorized Representative also. Medical device manufacturers should be responsible for keeping the technical file up to date and in compliance with general safety and performance requirements Annex I, Annex II, and Annex III of MDR 201 7/745.
- 10. Consultant of TechnicalFiles for Medical Devices Our regulatory consultants in Maven who are experienced in various fields of Medical Device Regulations are well versed in taking care of technical documentation like clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering files, safety and biological evaluation, and chemical characteristics evaluation.
- 11. Maven as adeveloping medical device regulatory consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The below mentioned activities are taken care by us Gap analysis of Medical Device T echnical file as per the requirement of EU-MDR Identification and classification of the medical device as per EU MDR
- 12. Help in selectionof conformity route of assessment and Notified body Preparation and Review of the technical documents as per EU MDR. Help to maintain and update the technical file post certification.
- 13.