A boutique consulting company focusing on providing clients comprehensive regulatory affairs and quality engineering services for medical device startups.

Why MDQR Solutions

With advances in machine learning and mobile technologies, companies are coming up with innovative products that promise patients a better life.  It can take months and sometimes years to bring a new medical device to market. Many start-ups often lack the staff or experience to navigate the complex journey to market. As medical devices are heavily regulated, trying to do this process yourself can lead to costly errors and many companies fail to navigate the FDA review process—often collecting the wrong data and then suffering a lengthy and protracted regulatory review.

At MDQR Solutions, we focus on building a robust scientific regulatory strategy that guides companies through product submission, with a deep-dive into the supporting engineering and clinical data, followed by a structured FDA submission. With the goal of reducing the regulatory review timeline and in developing a high quality product, we collaborate with you on the entire regulatory review process and on quality engineering, from requirements to risk assessment to verification and validation strategies, and everything in between.