How to set up your website to help you efficiently comply with Medical Device Regulations
The new EU Medical Device Regulations (745/2017) are now in force and by 2020 you will need to fully comply with them for all of your Medical Devices. These regulations require you to publish user information (instructions for use, user manuals etc.) for your device online. Your device information needs to be in all languages of the EU countries the device in which it is sold. And you will need to provide access to all previous versions (this is a requirement of Directive (EU) 207/2012 that applies to e-labelling). Easy access to this information means your website is an ideal place to store it.
Medical device manufacturers will need to do the following:
- Publish user information – instructions for use or user manuals
- Keep older versions for reference
- Make it available in all languages of EU companies where your device is sold to
- Provide easy access to your medical device product information
This article is also published on Morris Healthcare Consulting.
Publishing user instructions and manuals
A website that is easy to quickly update and add new content
We create websites that can be updated by any member of your team, without the need for any code or technical expertise. Providing you with a website that includes an easy-to-use Content Mangement System (CMS). You will have a user-friendly dashboard to help you to easily upload essential and critical documents, white-papers, device guides, manuals and instructions as soon as you need to. A website that you can update quickly, keeps you compliant and provides the information your customers need.
Our expertise is in partnering and helping medical device companies like yours to create a website and online presence that presents you as the leaders in your field with the very latest resources and provide documents that help your customers. Helping you towards your compliance with the latest Medical Device Regulations.
Keep older versions for reference
Archives and filterable resource libraries
We can create a website that presents an archive of historic resources so that your customers always have the instructions or manuals for older versions of devices. Resources could be a filterable archive or an easy-to-use library of your instruction manuals and guides for your customers.
The more you can make a visit to your website a pleasurable experience, the more your customers will remain loyal to your brand. People love easy and don't want to have to struggle to find the information they need. We can help you to present an easy route for your visitors to find what they need.
Provide easy access to your medical device product information
User Experience design. Your website visitors find what they need, quickly
User Experience and Information Architecture are critical factors when planning website content. The easier your website is to use by visitors means they will stay longer, dig deeper and quickly find what they need.
The earlier you can plan the journey your users take, the better your website will be for your visitors. We can help you plan your website structure so that critical information is readily available, with logical navigation and optimised resources.
When we work with you to create your medical device website and online presence we take the time to consider the essential process of considering your user's journey or interaction from one page or resource to the next. We visually plan this with you; with wire-frames, site plans, user journey flow diagrams right at the start of your project, so you can be confident that when your website is completed and live, your visitors will enjoy their visit to your site. Which means you can sell more and increase customer loyalty.
In all languages of the EU companies that your device is sold to
Experienced in multilingual website development
We can create your website in a range of languages. Having your content available in the local language of your customers will provide them with a tailored experience. We have experience creating multi-language websites that are easy for you to manage and update and easy for your customers to change language at the click on an icon. Behind the scenes, this may not necessarily be just a change of language, it can have local information and a completely tailored experience for their location.
Take a look at our website project case studies and multilingual website projects.
New compliance doesn't have to be a painful experience. We work with you to make the latest requirements a positive for your medical device business and for your online visitors. There are key areas to develop on your website that will help you to comply – resource centres, libraries, filterable assets, access to instruction manuals and user guides – all presented in an easy-to-find journey for your visitors.
If you need help with your current website or if you are thinking of a website refresh, contact us at [email protected] and we can chat about your project.
We also offer a Free 30-minute website project accelerator session delivered by video meeting, providing you with instant insight and actions you can take right now for your project.
Expert guidance for this article.
Expert guidance for this article has been provided by our colleague Dr. Keith Morris of Morris Healthcare Consulting Ltd. Morris Healthcare Consulting provides regulatory and market access services particularly for early-stage start-up companies and small to medium size enterprises that are developing medical devices (including in vitro diagnostic device and software as medical devices) and are typically first-time entrants to the market. This article also appears on the Morris Healthcare Consulting website.