Manufacturers of medical devices, including wheelchairs and mobility scooters, must adhere to regulations governing their products in order to secure access to world markets. These regulations, such as the European Medical Device Directive 93/42/EEC (MDD), are in place to protect the health and safety of consumers.
For over 30 years, we have provided wheelchair and mobility scooter manufacturers with testing and inspection services, including assessments of pre-sale literature, user manuals, service documentation and permanent labelling. All testing is based on harmonized product standards, and results are submitted in a clear, fully detailed report under accreditation.
As a member of the Dutch national mirror committee for wheelchairs, we are well-informed regarding potential changes to current standards as well as the development, over time, of testing methods. We are thus uniquely positioned to provide advice and carry out inspections that enable you to launch your products in markets around the globe.
Contact us and learn more about our wheelchair and mobility device services.
Bringing your products to market quickly and efficiently keeps you a step ahead of competitors. With our comprehensive in-house testing services, we have the resources to guarantee fast delivery times and global customer service, all at competitive prices. Our contact persons are at your side for direct communication and efficient project management. This allows you flexible planning.
Our testing services are designed to support the CE marking - RO process, encompassing mechanical and durability tests, electrical safety and electromagnetic compatibility (EMC) tests, and additional testing.
The testing concludes with an expert review of all product documentation and a final report.
Our portfolio of services for certifying wheelchairs and mobility scooters includes various systematic tests in compliance with a whole range of standards:
In addition to these specific standards for wheelchairs and mobility scooters, we are also able to perform quality management certification in accordance with ISO 13485 - RO and/or ISO 9001.
Wheelchairs and mobility scooters are Class I medical products according to the European MDD, meaning that manufacturers can declare for their own responsibility that their products comply with the essential requirements established in Directive 93/42/EEC. Once manufacturers have compiled a technical dossier (including a risk analysis and their own Declaration of Conformity regarding directive requirements), they can apply for the CE mark and launch their products on the market. Below is an overview of applicable European standards:
As an experienced and respected third party provider we work globally and customer-oriented. But our services go beyond ensuring compliance. Our laboratories are equipped with state-of-the-art facilities, including one of the largest wheelchair testing ramps in the world. And in addition to our ability to perform validity tests in accordance with international standards, we also offer our clients the opportunity to use our testing set-up to perform customer-specific research and development (R&D) tests under the supervision of one of our experts.
Contact us and speak to a service engineer about our testing services.