Medical device certification is complex and expensive. Medical products of higher risk class must undergo a series of rigorous tests before they are released for sale.
MedTech companies must comply with strict product safety regulations and pay extra attention to various regulatory and compliance standards. As a result, they often feel lost in the regulatory maze and turn to us for help!
Medical device manufacturers must face several challenges before they can place their products on the market of their choice.
We help MedTech companies overcome the complexity of the regulatory framework and understand the product safety requirements as best as they can. Our digital approach to CE marking medical devices helps companies cut their costs and time to market drastically. For instance, manufacturers of class I devices can get their products on the market in less than two months.
Our approach to medical device certification includes the following elements:
We will assign you one of our CE experts, and they will guide throughout the entire CE marking certification process of your medical device. The expert will start the process by reviewing your existing product development documentation, classifying your product and performing a GAP analysis.
Our service for CE marking self-certification of medical devices is based on expert guidance via web workshops and templates. Once the GAP analysis is finalised, our expert will prepare an action plan, considering your web workshops' availability. The action plan includes the date, time and agenda of each web workshop. You can have as many workshops as you need to complete the CE marking certification process. Each workshop lasts about 1 - 1.5h.
Once the action plan is ready, we'll provide you with all the templates needed for your medical device CE marking certification under the MDD, MDR, IVDD or IVDR. The expert will then show you how to fill them out via web workshops and review the work as you go along to ensure everything is done correctly. At the end of the process, you will receive a Declaration of Conformity.
The templates include documents, such as risk assessment file, hazards report, quality management system, classification report, verification report, Declaration of Conformity, and more
Some class I medical devices and products of class II and III, need to pass accredited testing and/or receive approval from an EU Notified Body. We will try to provide the necessary assistance if requested.
We partner with several accredited test labs and Notified Bodies that can provide conformity services for both medical hardware devices and medical software devices.
Access our digital compliance marketplace to browse our services or get in touch with us directly.