Class III Device Manufacturer
“We truly appreciate the leadership you provided for our regulatory team and your thoughtful approach to compiling the [product] PMA submission. We were not expecting an external consultant to learn the product so quickly or meet the aggressive submission deadline.”
Manufacturer, CMO, and Component Supplier
“Your [Quality Management System] training is the best I have attended in person or online.”
“Thanks to you, we received our ISO 13485:2016 certificate today. Thank you so much for your support in helping us prepare.”
“You were a large part of helping us through this [regulatory inspection]”
Class I, IIa, and IIb Medical Device Manufacturer
“I really appreciate all your help with this project. Your deliverables were very well thought out and organized, your responses were timely, and you really took a lot of stress off my shoulders. I feel so much better about what we are submitting to [the notified body], and as a whole, it was a big learning experience for [the company].”
Class I and II Medical Device Manufacturer
“Bryan, the logo on your website is so true - ‘on your side not over your head’. You made the requirements easier to understand and implement. Thank you for quickly getting our device cleared by the FDA.”
“You are one of the few people in my professional life who SOLVES problems rather than creates them!”
HCT/P Processor (Tissue Bank)
“The support and mentorship you provide to the team is much appreciated. Having someone with your expertise available has been an advantage to [company name].”