The regulatory environment for medical devices companies is becoming more complex, requiring companies to understand and adapt to new regulatory requirements. A good example is the Medical Devices Regulation (MDR) in Europe, which replaces directives and comes into force in 2020. These new EU MDR regulations, along with changing expectations globally, place additional pressure on regulatory, quality, and clinical departments.
Celegence provides expert medical device regulatory consulting for every step of the medical device product lifecycle. Our proven processes help you interpret and meet country-specific requirements. Our global team of medical regulatory experts will develop the optimal regulatory strategy, depending on the device and market targeted by your organization.
Our team of regulatory scientific writers can handle all your medical device submission requirements, including carrying out all Clinical Evaluation Reports (CER) writing on your behalf. And our deep knowledge of the regulations and processes allow us to speed up the medical device registration and submission process.