MDRC creates technical documentation complying with FDA regulatory requirements. We prepare technical files for all product classes and all regulatory procedures (510(k) exemption, 510(k), Premarket Approval).

According to the FDA regulations medical device companies must implement and maintain a risk management system. MDRC helps manufacturers create FDA-compliant risk management systems.

Clinical evaluation based on current scientific and clinical data is necessary for all devices that do not go through clinical investigations. We can carry out clinical evaluations for your products and compile documentation that complies with the provisions of the FDA medical device regulations.

The classification of medical devices in the USA is based on determining substantial equivalence of your product and a predicate device (a medical device previously cleared by FDA). This is done by searching for predicate devices in the FDA database. MDRC can search the database and perform classification of your products.

Post-market surveillance system is a binding requirement in the USA. It is an integral part of the medical device manufacturer's quality management system. How the system is organized and how it works depends on the risk-based classification of products a company manufactures and sells. MDRC will create the post-market surveillance documentation and help you elaborate and implement the system.

It is not unusual that medical device companies who are interested in the US market need to actively collaborate with the FDA. To communicate with the agency effectively you need to deeply understand the US regulatory framework. We have this understanding and knowledge. We can take on a lot of FDA-communication or help you in making your communication with FDA most effective.

FDA does not recognize ISO 13485 certificates. The American regulatory agency has its own standard 21 CFR Part 820, and companies placing their medical devices on the American market have to conform to this standard. Additionally, being a member of MDSAP program FDA recognizes MDSAP quality system certificates. MDRC can help you implement a 21 CFR 820- or MDSAP-compliant quality management system.

In the US almost all class III devices and approximately 10-15% of class II devices, which are not 510(k) exempts, require clinical investigations. Usually, FDA recognizes clinical investigations conducted outside the United States provided that they comply with the international clinical research standards. MDRC will help you figure out what investigations are required, how to conduct them efficiently, what investigations can be waived etc. We also can organize clinical investigations for you.