AcKnowledge Regulatory Strategies

AcKnowledge Regulatory Strategies specializes in Regulatory Affairs (RA) consulting exclusively for the medical device and In Vitro Diagnostic (IVD) industry. When you hire us, you also hire our entire network of current and former FDA reviewers, scientists, engineers, and regulatory/quality experts. We understand that each medical device needs a specific and tailored strategy to earn regulatory clearance. We strive to work with the FDA to ease the review process and get your device on the market faster than our competitors.

Once you engage our services, we will set up a specific plan for your device or product so you have a clear understanding of what is necessary, when it’s needed, and why it’s required. Our goal is to ensure that you have well-defined expectations so we can work together to see your technology brought to market.

Company’s Keywords:

medical device, regulatory affairs, biocompatibility requirements, combination products, fda submissions, 510, presubmission, de novo, ide, breakthrough designation