All contents of the technical file should be included in the design dossier, as the purpose of the technical file is to demonstrate conformity with the applicable directives or regulations. Additionally, the European MDD allows manufacturers of Class I medical devices to carry out their own conformity assessment activities because of the low-risk classification associated with the product.
The design dossier should include the technical documentation, along with a declaration of conformity and a description of the design, manufacturing, and performance of the device.
Medical device companies will still be required to maintain technical documentation respective to their products, and requirements for CE markings will remain roughly the same. One important change to note is the term "design dossier" will be replaced with "technical documentation. Here are some the key changes, items to expect during transition, and steps to take for compliance. Read Blog Post. January 13, at 8am to January 14, at 2pm — online. January 13, from 10am to 1pm — online.
January 14, from 10am to 1pm — online. Powered by. Badges Report an Issue Terms of Service. MedTech I. Academia Industry Government. Answers Box.
A thorough understanding of Design History File, the Technical File and the Design Dossier is necessary All the complexities and in-depth clarification relating to these subtle matters about medical device regulatory requirements will be unraveled at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.
Views: Tags: Like. This or the other file is irrelevant, what matters is how you use those files in your job. In my opinion, I think that the DHF is more useful. The reason for this is because this document is able to show a detailed and comprehensive design and development process until its release.
Every change, every choice taken towards the design of the device, every mistake and every path taken is in the DHF and anyone that open the DHF is able to see how the device evolved from beginning to end. Every reference needed to make the device is in there, compared to the tech file in which it is just a snapshot of the design. It does not really tell you what changes where made and why, plus it does not contain any required SOP to follow.
The DHF also, demonstrates that the design was developed in a coherent quality plan and a coherent set of requirements. I have to defiantly agree with neb2, the DHF is a lot more useful than the design dossier since this file have detailed information bout the design, function, composition, use, claims and clinical evaluation of the medical device and it seem important but there a lot other information that is missing and I believe that the DHF have a lot of more crucial information that can be really useful for the medical device.
We be able to learn a lot more using the DHF than using the design dossier. The files are very important in both the design and development process of creating a medical device from start to finish. However, if a DHF is put together correctly by the team, then a technical file, which is primarily a snapshot of the design, can certainly be placed into the DHF.
The DHF is a simply the collection of documents from the design to the development process. It is key file that contains all the design controls documentation and therefore it is a requirement by the FDA for the k submission. A technical file is very similar version to a DHF except that is a European version for the k. The technical file mostly explains that how is a particular product related or conforms to an applicable EU medical device regulations.
Although, the technical file follows a format but it is less descriptive. The very big difference between the two documents is the need to submit a clinical evaluation report with the technical file. Both are very important documents and carry weightage in different regions. However the DHF is more detailed and thorough because of its existence from the initial stage. DHF contains detailed design plan,design input,design output,risk analysis,design verification and design validation and design transfer.
Technical file describe the product at a point in time includes some elements of DHF like risk management documents and clinical data. DHF is more detailed than technical file,it is more useful.
Tech File is easier, but DHF more useful. DHF : A compilation of records that contain the history of the design, such as validations, verification, qualifications, environmental testing, project plans, risk management activities, meeting minutes,design reviews etc. Often this will include all revisions of a procedure, drawings, etc. FDA ensure safety and efficacy.
But Tech file Shows snap shot of design. Another difference is the Tech File as Dr. Simon mentioned in lecture, it has a set format. For the Tech file, requires going through verification and design validation first, whereas you just need to be through verification for the k.
0コメント