Blue Curve are medical device design & safety engineering experts. If you need help getting your medical device from the lab bench to the market, we have a range of services to assist you.
Blue Curve focus only on regulated medical devices and in-vitro diagnostics. This enables us to deeply understand your product, and to get product design, safety and registration right first time.
Blue Curve are experts on the FDA-CE-TGA-ISO-IEC standards that are required to build and register medical devices. We provide design, safety, manufacturing and regulatory expertise across the entire medical product lifecycle – product & development planning, verification, risk, safety, validation and manufacturing transfer.
This includes a range of support services for medical devices undergoing clinical trials.