The portfolio of medical devices for which she has approval are plastic products with measuring function, various creams and gels, different systems for wound care, disinfectants, dental materials, different catheters, panels for operating rooms and clean rooms, accessories and kits for performing surgical procedures of non-woven materials, medical gases, and various dental materials.
The toolkit documents are organized to guide you on your implementation path. They’re structured in clearly numbered folders, so that you know where to start, and – after each document is completed – where to go next.
We’ve done 80% of the work a consultant would charge you for. Anything that can be prefilled in the documents is already done, and the remaining adaptation you need to do is clearly marked with comments and instructions.
Simply move through the documents, filling in the specifics for your company as instructed. Our experts have even added some instructions on what to enter, to help you move through the implementation as efficiently as possible.
Completing some parts of a document might be a challenge for you if you’ve never done this before. In these cases, we’ve added detailed instructions and, where needed, links to articles that will help you understand and complete these sections.
Most companies have a specific design and structure for their official documents. There’s header information, confidentiality level, even prescribed graphic design and fonts. All of our documents are fully customizable, so that you can make them look just the way they should.
ISO 13485 certification is much more than just documentation. The implementation of the standard needs to be appropriate to your company, and you need to deal with your employees, your management, and your existing processes in an appropriate way.
This is why our experts are on hand with live online support to answer any difficult questions – we can set up a call via Skype, over the telephone, or through any other method convenient for you; or, we can answer your questions via email – whatever suits you best.
[name, job title]has been appointed project sponsor.
Our documentation toolkit includes ISO 13485, ISO 14971 and EU MDR templates for every single document you need – all fully acceptable for certification audit.
For a complete list of included documents, please click here.
We have already filled in about 90% of the information for you. For most documents, you’ll just need to enter the particulars for your organization: business name, responsible parties, and any other information unique to your company. Each document guides you through the process, including comments on which elements are required, and which are optional.
We take the guesswork out of ISO 13485, EU MDR & ISO 14971 documentation, so you can rest assured you’ve completed everything accurately and with the utmost efficiency.
13485Academy is known for its quality and accuracy, and you can rest easy knowing that each document in our toolkit has been written and double-checked by top ISO 13485, ISO 14971 and EU MDR experts. Our templates are designed to make completion quick and easy, taking the frustration out of the implementation process.
Each document is ordered so that you can follow its sequence perfectly. By following each step in order, you make sure nothing is missed, and that no one gets lost in the process. Included flowcharts help employees understand each process to make quality management easier, and processes easier to follow.
The ISO 13485 & EU MDR Toolkit was created specifically for Small and Medium Businesses and supplying companies to reduce the costs (in money and time) of implementation. With our toolkit, we don’t make you complete every document that a major multi-national corporation would need. Instead, our toolkit contains only the documents needed for YOUR business.
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Please do! Click on the “DOWNLOAD FREE TOOLKIT DEMO” button and enter your name and your email address. You can instantly access a free preview of each document template, helping you make up your mind. This is a great chance to see how each document looks, and how easy they are to complete.
Yes. Also, you are entitled to receive free updates of those toolkits for one year after your purchase date.