Achieving Your Medical Device Regulatory Goals Begins With a Comprehensive Strategy

At RCRI, we know that achieving your medical device regulatory goals begins with a comprehensive strategy. We have extensive worldwide experience with regulatory bodies in over twenty countries, and can help you strategize your market approach from conception to completion.

When launching a new product, it’s imperative to understand medical device regulatory requirements in multiple markets. RCRI has the experience and successful history working with clients to create new medical products that meet regulatory requirements in multiple markets. By starting with the end goal in mind, our comprehensive strategic consulting services can save you time, money and effort.

RCRI Regulatory and Quality Systems services brochure

Integrated Approach to Medical Device Quality Systems Offers Comprehensive Solutions

RCRI’s integrated approach to medical device quality systems provides you with the peace of mind that only experience offers.  Because we examine all aspects of medical device quality systems, we often uncover potential risks, and can offer you the benefit of our experience to explore the pros and cons of such risks. We’ve developed novel and targeted strategies over the years to help our clients achieve regulatory approval in multiple markets; your firm can benefit greatly from working with such experienced consultants.

Efficient Medical Device Regulatory Processes Start with an Experienced Strategic Consultant

The medical device regulatory process can be efficient and smooth when you work with experienced strategic consultants. Choose RCRI for innovative, creative solutions; comprehensive and thorough research; and the insights only time and experience bring to your projects.

RCRI has Experts in Unique Device Identifier Regulations

RCRI can help you meet the FDA requirements for Unique Device Identifier, also known as UDI. UDI is a unique number or alpha-numeric code that is specific to that device model’s production information (e.g. lot, batch, serial number, or expiration date). The FDA believes the UDI has the potential to improve the quality of information about device problems. Our UDI Consultants can help you navigate the requirements.

Contact us today for an appointment and consultation.

Share Button

Regulatory and Clinical Research Institute

5353 Wayzata Boulevard, Suite 505, Minneapolis, MN 55416-1334 USA | | 952.746.8080

©2017 RCRI. All rights reserved.