ISO 13485 & MDR Integrated Documentation Toolkit

Templates for every required document

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’ve done most of the work for you – documents are 90% complete

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.

Created by experts

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.

Fully editable documents

Every document is available in either MS Word or MS Excel, making them a breeze to customize for your company. Maintain branding by adding company logos and colors, and edit headers and footers to match your preferred style.

Clearly organized, logical steps

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.

Standardized formatting

Each document in the toolkit follows an identical structure and format to help you speed through completion efficiently and accurately. Further, to help you understand relationships between each document, we cross-reference all documents.

Created especially for Small and Medium Businesses

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.