As all the information on the technical documentation is linked. This section is always tricky. Some medical device manufacturers are starting to design their products without a real Quality Management System structure from the beginning which makes it difficult to show compliance to this section retrospectively.
But if you have made your job right, you can then provide information about the design process with the different milestones you reached.
A reference to a procedure can be great. You can mention the different design stages related to the product, but you may also need to provide a link to those documents. So a table with a reference number to a controlled document is recommended. When I say a controlled document, this means a document that you can track on your quality management system. Something with a reference number, a version, a place where we can see who approved it.
For the manufacturing information, this is important to have a high-level schematic of how this product is produced. A flowchart would make sense. So I recommend you to use a third party to evaluate if this is understandable. The problem with a Notified Body question is not the question, it is the time that you will lose to finalize the review.
More questions there is, less time the reviewer will have to finalize your dossier. Because while you will work on the answer to the question, he will start to work on another dossier.
So you are back in the queue. For example, you should mention the entity that performed the design in the case not done by you. Same if you are the legal manufacturer but not the manufacturer. I am thinking for example of companies that need the support of other entities to manufacture the product for them.
Additionally, you should also list your critical suppliers as the entities performing sterilization, cleaning, final inspection, assembly, packaging…. There are some differences in the wording and also some new requirements. This is a template that you should fill by providing a proof for all the 23 requirements listed. Check my shop. This is section is important as this is to define the risks related to your products. For medical device companies, this is following ISO So you need to have a procedure for risk management and then issue some risk assessment for your products.
This risk assessment can have multiple formats but the most known one is the FMEA format. You will then identify the risk related to your products. But this may be the subject of another blog post as this can be complicated.
So this is important to include them in this section to be sure to be compliant to it. I think this section will be the most important one to prove the safety and performance of your product.
So stay focused. This section is related to the product itself in terms of all the tests that you should do to provide evidence of:. So be patient when you are building this section of the technical documentation as you will have to review each of those elements and provide a piece of evidence that you comply with the requirements. For example, there are some combination products or products that use animal tissue or products that contain CMRs. If this is applicable you should complete the related section on the Technical Documentation.
All the clinical data are critical to proving the safety of your product. Without clinical data, you will not be able to get approval from your Notified Body. See below. This is specific to Post-market Surveillance. There is now an emphasis t to perform a proactive review of the performance of your product.
All this information should be available for review on your technical documentation. Same as what I advised previously, you can also list some documents and then attach them in the annex. This will be more convenient for the reading phase. PMS is really a big topic, so a set of procedures should also be created on your Quality Management System. He introduces to us a new feature that will help you to perform your PMS in an easier way. So we arrived at the end. I can imagine that now you understand there is a lot of work to gather all this information.
This will help you to have the right structure for your technical documentation and some guidance is provided to help you understand what is expected in each section. You can get it here. I will be happy to discuss your project with you. Just click the Red Phone logo below to activate a messenger chat. Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market.
My objective is to share my knowledge and experience with the community of people working in the Medical Device field. He proposes his consulting services so don't hesitate to contact him at info easymedicaldevice. I teach you on this article all that you need to follow to put it on the market. I developed a 3 step program to put any medical device on the market.
The Route Plan. You need to plan all before to start your journey. I explain to you who can be PRRC and what are its responsibilities. Don't wait to nominate yours as there are also some changes to do with the quality documentation to be fully compliant. FDA rejects a majority of the k submissions due to Substantial Equivalence issues. We propose you to learn how to master Substantial Equivalence and always succeed. Learn also what to do in case of rejection. This article is a Step by Step process to succeed on you Substantial Equivalence section for the process K.
Table of Contents. Who will review your Technical Documentation? Learn more. Where can you find the Technical Documentation information? Download ISO What is the structure of a Technical Documentation? Device description. This will provide a high-level understanding of the full technical documentation as here you will provide some information as Intended use, product name, reference numbers, variants, product classification, conformity assessment … This is really an important section to have a broad understanding of your product and also to get the different references linked to it.
What is expected also if to provide a copy of the exact labels and IFUs with version numbers etc… I recommend you to create a table with different products and document references in this section and then place true documents as an annex. This should also have your unique device identification UDI number. Labeling and instructions for use. Note: You will need a translation for the local language of the EU country you plan to enter. Detailed information on design and manufacturing.
It is recommended that you make use of flow charts to clearly show processes and relationships. You need to show the manufacturing process, suppliers, and materials used. Detailed risk management information in compliance with ISO It identifies all the things you must do for your device type. From a design control perspective, the contents of your traceability matrix will assist you with addressing the criteria of GSPR.
Verification and validation information. In terms of verification and validation, the European Commission places a heavy emphasis on clinical data - not just during design and development, but post-market, too. You can find more information on the requirements for the various types of technical documentation in the MDR.
For example:. I recommend conducting your own internal audit review. This should be carried out by a cross-functional team of design and development, quality, regulatory, and even manufacturing stakeholders.
It can be invaluable to have someone come in who already has expertise on your specific type of project. Greenlight Guru has a worldwide network of trusted partners who have specific expertise with technical documentation. You can access the full session replays here to learn more about these speakers and their areas of expertise. Externally, the technical file is reviewed by a notified body, who assesses the technical documentation to determine whether all requirements have been met in order for certification to be given.
There is an expectation that a technical file should be a living document that is kept within the quality management system, alongside other key artifacts, throughout the entire product lifecycle. This would be extremely difficult to do using a paper-based system that involves manually updating and maintaining stacks upon stacks of physical documents and reports. Conversely, a robust quality system that automatically manages your technical file, PMS reporting, and helps you maintain compliance is a clear winner.
Greenlight Guru is the only QMS software that is purpose-built for the medical device industry and makes the entire technical file process seamless. Looking for a design control solution to help you bring safer medical devices to market faster with less risk? See the Demo. Subscribe See the Demo. Search Results for:. Technical file overview The technical file has been around for a long time.
The EU MDR states that medical device manufacturers must: Prepare technical documentation before placing a product on the market. What is the structure of technical documentation? At a minimum, technical documentation should have: A device description and specification section.
A seamless solution for managing your medical device technical file There is an expectation that a technical file should be a living document that is kept within the quality management system, alongside other key artifacts, throughout the entire product lifecycle.
0コメント