Medical device companies who are interested in EU, USA or Latin American markets often need liaison with regulatory authorities of these countries. To communicate with the regulatory authorities effectively you need to deeply understand regulatory frameworks of your strategic markets and the regulatory procedures applicable to your medical devices.
Medical device companies who are interested in EU, USA or Latin American markets often need liaison with regulatory authorities of these countries. To communicate with the regulatory authorities effectively you need to deeply understand regulatory frameworks of your strategic markets and the regulatory procedures applicable to your medical devices.
We assist medical device companies with their regulatory communication strategies. We can figure out how your company should communicate with the regulators, whether you need to directly contact them, how to perform the regulatory submissions, and if your medical devices require scientific advice.
Initial contact - we will help you find the right department of a regulatory agency, right people to contact with and contact them on your behalf. This will streamline your communication with the regulatory authorities and make it effective.
Routine communication with the regulatory agencies on project matters. We can take on all communication with the regulators occurring as a part of every project you are working on. This will save you a lot of time and resources and help you make the best of your work with the regulators.
Scientific advice with regulatory agencies. In some cases medical device companies can request scientific advising from the regulatory authorities regarding medical device classification, safety, clinical program etc. Scientific advice can be in written or in oral form (this is up to the advisors). It requires a thorough preparation and should be properly organized. We will help you prepare, organize and conduct scientific advice for your products.
Filling out forms for regulatory submissions is an onerous task. We can do it for you. We will prepare all documents for your submissions and file them with appropriate authority as required.
We assist medical device companies with their regulatory communication strategies. We can figure out how your company should communicate with the regulators, whether you need to directly contact them, how to perform the regulatory submissions, and if your medical devices require scientific advice.
Initial contact - we will help you find the right department of a regulatory agency, right people to contact with and contact them on your behalf. This will streamline your communication with the regulatory authorities and make it effective.
Routine communication with the regulatory agencies on project matters. We can take on all communication with the regulators occurring as a part of every project you are working on. This will save you a lot of time and resources and help you make the best of your work with the regulators.
Scientific advice with regulatory agencies. In some cases medical device companies can request scientific advising from the regulatory authorities regarding medical device classification, safety, clinical program etc. Scientific advice can be in written or in oral form (this is up to the advisors). It requires a thorough preparation and should be properly organized. We will help you prepare, organize and conduct scientific advice for your products.
Filling out forms for regulatory submissions is an onerous task. We can do it for you. We will prepare all documents for your submissions and file them with appropriate authority as required.
MDRC is your interface with regulatory agencies and notified bodies.
whether you have a question about our solutions or need help with your new project
