CONSULTANCY
ACCESS TO THE MEDICAL DEVICE MARKET
Enfisa has been helping medical device and IVD companies with regulatory compliance and market entry since 2014. We have offices in more than 6 countries, offering a wide range of compliance services, including regulatory strategy, registration of devices, compliance with the quality management system and regulatory representation in the country.
CONSULTANCY
RA/QA
It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With the help of Enfisa medical device RA/QA consultants, you can follow the most efficient regulatory route for the approval and registration of your device, and maintain compliance with post-market requirements.
Determination and Evaluation of the classification of medical devices and IDVs
Classifying your medical device is an important first step in the device registration process. Your device class dictates your regulatory roadmap, including required documentation, clinical data and study requirements, safety testing requirements, and more. Our team performs the most difficult classification evaluations for novel, borderline and combination products. If applicable, we will work with you to find answers from regulatory authorities on the appropriate classification for your product through pre-submission meetings.
Marketing Strategy for Medical Device Companies
Because we work in so many different markets, we fully understand the complex national regulations and where they overlap. We apply this knowledge to your benefit in a way that could not be achieved by working with separate consultancies or affiliates with limited local experience. We will develop customized regulatory strategies that leverage your existing registrations. Whether you have one product or hundreds, we can help you expand your market in Chile.
