Addressing a Changing
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: Global Expertise for Medical Devices
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.
Celegence Helps You Meet Changing Medical Devices Regulatory Requirements with the Following Niche Services
- Global regulatory and market Intelligence including overviews on country-specific requirements or regulations including product classification, clinical trial study requirements, and import regulations
EU MDR consulting services to support transition to the new regulations
Assessment of Post-Market Clinical Follow-up study requirements for your device and assistance with developing a plan, designing the study, and conducting data analysis
Expert guidance on CE regulations and clinical literature reviews to help you meet changes for MDR
CE Marking projects including classification, clinical or performance evaluation, validation, technical documentation and post-market activities
IVDR classification, combination product classification, and filing support
Guidance for Implementation of Unique Device Identification (UDI) and related services
Literature searches and writing as well as SOP development
Creation of technical files
If you’re curious how Celegence can help improve your Regulatory Operations for medical devices, fill out the below form and one of our team members will get in touch with you.