Regulatory Affairs

A wide array of regulatory affairs support.
100 percent focused on devices.

At Devicia we focus exclusively on regulatory affairs services for medical device developers. Based on our experience, a lean regulatory process is just as important as how your product is designed, manufactured and marketed. We offer regulatory services to make your time-to-market as agile, safe and swift as possible.

  • Efficient regulatory affairs
    through your device lifecycle

    Regulations for medical devices differ substantially from those of pharmaceutical and drug development. Working with us gives you access to our data management system, developed for documenting and monitoring all stages of your device’s lifecycle. The system offers complete transparency for you and any stakeholder you want to include in the workflow.

  • Actively supporting
    you in regulatory affairs

    Regulations for medical devices differ substantially from those of pharmaceutical products. However, borderline cases, where it is not clear from the outset whether a given product falls under the pharmaceutical or medical device regulations, exists. This fact, combined with the changing regulatory framework, constitutes some of the challenges medical device companies face. We support you in handling challenges and questions arising throughout your medical device life cycle. Please contact us for more information on how Devicia can help your company navigate throughout the regulatory requirements.

Our regulatory affairs services include:

Managing all phases of CE certification and CE-marking
Managing all aspects of FDA (e.g. IDE’s, 510(k)s)
Clinical trial applications
Marketing applications
Medical writing
Publishing and submissions
Lifecycle management
Preclinical and CMC consulting
Agency interactions
Strategic consulting and intelligence
Quality review
Want to know more about
our regulatory affairs consulting services?
Contact our regulatory team