Medical Devices Regulation
The new Medical Devices Regulation (MDR) comes into effect tomorrow and we are delighted to announce that the products listed below are compliant with this EU standard.
The regulations bring many benefits to Assistive Technology products from the initial concept design, the processes of development and manufacturing, and finally, to the assessment, training and ongoing support of the user.
We, as a manufacturer, have seen an improvement in our Quality Management system, the methods by which we respond to faults with quick corrective actions, the traceability of our products in the supply chain, the quality of our instruction manuals and literature, and the way in which we will bring new user driven products to the market.
For the end-user it provides assurance that the technology they are using to support their daily lives satisfy the highest standards of performance and safety and that there is a clear and well-defined pathway to obtaining support and training into the future.
Declarations of Conformity (DoC)
Obligations for our resellers
If you import any medical device products into the EU please make yourself aware of Article 13 – Obligations of importers in the regulations.
If you sell any medical device products to distributors within any EU country, we recommend you alert them to Article 14 – General obligations of distributors.
