We are ISO 21001 : 2018 Certified
We are ISO 21001 : 2018 Certified
The most important element of getting your medical device approved is the implementation of a fundamental regulatory strategy and sound technical documentation.
Whether you have an existing device, an improved model, or a brand-new idea, RAAJ has all the knowledge and regulatory experience that you will need, to face the challenges involved in placing your medical devices on the market and keeping them compliant. You can leverage our expertise, taking the pain of regulation out of your business and speeding up the process. We have been supporting medical device companies for many years, in multiple markets. Our team can help you navigate all areas of quality assurance and regulatory affairs.
Our regulatory team provides you guidance and support to comply with the correct medical device regulation and market access requirements with a tailor-made service package we can provide excellent and efficient support in preparing access to global markets.