Hi, my name is Bernhardt. I am rewellio co-founder and I am dealing with regulatory affairs and compliance issues. Sounds a bit prosaic and boring? Well, let me tell you about my job at rewellio and the world of medical devices!
The world of medical devices and health care industry in general, is a quite heavily regulated environment. Manufacturers, distributors, dealers and of course, the medical device itself need to comply with a variety of pretty strict regulations, standards and norms, to make sure the product is appropriately designed, developed and manufactured in a good manner. National competent authorities monitor medical devices and manufacturers on compliance with the required regulations.
All this effort for a very very good reason: to protect your health and safety.
Whenever you see a marking as for example a CE-marking, FDA approved or similar on your medical device, you can be sure that this product and its manufacturer is complying with all required national regulations and is being monitored by a competent authority. That provides quite a good feeling on the products’ quality and safety, right?
What are we doing to protect your health?
Rewellio is following a risk management based approach on every single step and phase of our company’s processes and product‘s lifecycle. By assessing and monitoring all possible or probably occurring risks throughout every phase, we make sure to have adequate counteracting procedures and actions in place, even before the risks occur.
We have an ISO compliant quality management system established ensuring the quality of our company processes, resources, work and products. We believe that only high class resources and well structured work, can deliver safe and effective high class medical devices.
Furthermore, we conduct scientific studies and analyze clinical data together with scientific and clinical partners, to make sure our rewellio app is delivering the desired effects at most comfortable usability. Therefore securing the most effective outcome for your therapy.
Rewellio is designed for minimal risks and developed for maximum outcome.
As Chief Regualtory & Compliance Officer, I am proud, my work contributes to the most important thing in our healthcare environment: our patients and their safety.
Currently rewellio is registered and approved as medical device in:
the European Union, registered with the Austrian national competent authority
Approved by the FDA in US (please click on the link for listing & registration details)
and approved by Health Canada.
Currently we are busy working on further registrations and certifications for other regions and countries as for example Australia.
If you want to know more on our activities regarding safety, risk – and quality, follow me on my journey together with rewellio or drop me an email!