Expert in product development, quality, and regulatory for healthcare products. Can help companies understand the applicable regulations, strategy, and deliverables for their product starting at concept to commercialization in any country desired.
Expert in healthcare product development, quality, and regulatory from concept to commercialization.
Looking for expert advise on product development, quality, or regulatory in the medical device space? I can help you understand all requirements or best practices when it comes to medical devices.
Need help understand requirements for submitting an FDA 510(k) application? Whether you have a Class I, II, or III hardware or software product, I can help simplify the process and ensure your application is setup for an effective and successful review.
Rory was very knowledgable and generous with his insights about the FDA approval process and helped us demystify several questions we had about regulation. I'd definitely consult with him again on this topic and recommend him to anyone looking for an expert on regulation for healthcare products.
Rory was very helpful and got me the information I needed on the call. Highly recommended!