This document is to provide a high-level overview of RCA’s MDR consultant solutions and the EU MDR requirements for manufacturers. Included is an outline of RCA’s EU MDR consultant Compliance and Implementation services based on these requirements. Both existing and new clients may be targeted as part of the marketing campaign for these new services. Download the full document below.

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s MDR consultant team can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including many expert MDR consultant, FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

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