“Jason at AssuraPath Consulting did a phenomenal job working with DiaCarta. He performed an internal audit to help us prepare for our ISO 13485 recertification audit, which helped us proactively identify gaps and areas of improvement. This proved to be highly beneficial during our recertification audit in showing our Notified Body we are aware of our compliance posture and committed to continual improvement.
Jason brings deep expertise in ISO 13485 and 21 CFR Part 820. His audit approach is detailed, pragmatic, and focused on practical solutions. He does not just identify issues; he provides clear and actionable guidance to help us address them efficiently and build long-term compliance. His professionalism and collaborative style makes him a trusted partner to our company.
Thanks to AssuraPath Consulting’s support, our team was well-prepared and ultimately successful in our recertification. I highly recommend Jason and AssuraPath Consulting to any life science or IVD company seeking a knowledgeable and strategic quality and regulatory partner.”
