MCRA Publications

Medical Device Quality: Why Software Is More Challenging Than Hardware

The Impact of U.S. Regulation on Medical Device Innovation

Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

For a company navigating a Class III medical device’s path to market, the U.S.

Four Questions to Help You Avoid Losing a CE Mark

A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it appli

Learn About Our Unique Approach to Your Challenges

MCRA combines world class know-how and execution in combination with providing your team with a hands-on, proactive, and team-based support at every step of your technology's life cycle.

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