What is needed
Medical devices like Wizzybug are regulated by the Medical Device Regulations (MDR). These regulations exist to ensure a high standard of safety and performance for critical products, ranging from assistive products such as wheelchairs to implantable devices such as pacemakers.
As a medical device manufacturer, we have to demonstrate that we are in full control of our product, from design through to delivery. This is achieved by adhering to a thorough set of procedures and standards relating not only to the product itself, but also our overall quality management system.
Why this is so important
Adherence to the MDR is a crucial legal requisite to being able to provide Wizzybugs in the UK and beyond. Without doing so, we would not be able to operate the Wizzybug Loan Scheme.
Equally as important is the backbone of safety and evidence that adherence provides, ensuring Wizzybug families are receiving a safe and effective product.
What we have done to date
Wizzybug was previously CE marked under the Medical Device Directive. After its replacement by the MDR in 2017 (to be fully implemented in May 2021), many elements of Wizzybug’s technical file and Designability’s quality management system have been updated and upgraded.
Ongoing work has involved strengthening of the processes and documentation associated with, but not limited to:
- Design & development
- Risk management
- Clinical evaluation, verification and validations
- Post-market surveillance
- Other business-wide operating procedures
Adherence to the MDR is not a one-time project. It is ever progressing as processes and products are improved and evolved. Within the design & engineering team, the smallest design change must pass through our robust risk management and change control processes. At the same time, the operations team are following processes to ensure quality in our supply chain.
Paving the way for new products
The quality of our output is ever improving as we implement and refine these new processes. Wizzybug will grow to new levels of performance, and so our processes, testing and documented evidence will grow to meet it. This will also pave the way for the development of new products in the future.