Medical Device Global Consulting:

Addressing a Changing
Regulatory Environment

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.

Medical Devices Regulatory Requirements

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

Additional Information

Download the latest brochure of our capabilities and services.

Pharmaceutical Industry Regulatory Affairs - Celegence

Contact Us

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.

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