“Our experience working with PASB and particularly Sarah Bassler has been fantastic. We were referred to PASB to help us understand how our health and wellness devices are regulated in Canada and the United States. PASB advises our global team on compliance in all aspects from labeling to electrical safety and quality requirements. Their advice is always well thought-out and they are very responsive to urgent requests. Thank you PASB for taking the time to understand our business! We look forward to working with you for many years to come.”
Elena Babcock, Regulatory & Product Safety Analyst, Amway
“PASB is enabling innovation in healthcare by providing companies with the quality tools and expertise they need to be successful. Paul and Sarah bring extensive knowledge of medical device regulations and have provided PolyUnity with an accessible, strategic approach that adapts best quality practices to fit our unique needs, all while keeping future growth top of mind. We have sincerely enjoyed working with them and strongly recommend their services to any organization trying to navigate regulatory pathways and achieve sustainable growth in the healthcare sector!”
Rachel Tobin, Project Engineer, PolyUnity Tech Inc.
“PASB was a fantastic group to work with. Helping with implementing our Quality Management Procedures and Policies, Paul & his team were incredibly diligent in their work with a high attention to detail. I would highly recommend PASB for all things regulatory, QA/QC and engineering/product development support.”
Brett Vokey, Founder and CEO, BreatheSuite
“As a medical device distributor, we really enjoy working with Sarah at PASB MedTech Solutions. PASB works hard to provide prompt, efficient service and have helped us tackle many difficult regulatory issues with an open and creative mind. Since FroggaBio began working with PASB we have successfully added a private label medical device to our offerings and obtained approvals to distribute several innovative highly complex medical devices in Canada. We trust them as a partner and would recommend PASB to any medical device distributor or manufacturer who wants to streamline their regulatory operations.”
Moshe Kapelnikov, Managing Director, FroggaBio
“Thanks Sarah and Paul for your tremendous help and diligence especially with the risk and V&V elements. I am 100% sure we would not have been able to close the submission w/o your support.”
Hasnaa Fatehi, Senior Mgr (Regulatory Affairs), I-MED Pharma
“Sarah Bassler at PASB helps with all Medical Device classifications for both US and Canada and is committed to finding the best path forward for our clients. I have worked with Sarah for the past 3 years and have experienced a truly gifted and knowledgeable Medical Device expert who responds quickly to questions and is always happy to help. Thank you Sarah for your high level of professionalism and for always being there when I need you.”
Jacqui Jenskey, Director of Regulatory Affairs, Dell Tech Laboratories
“RAR Innovations is a medical technology startup based in St. John's, Newfoundland. We were introduced to PASB MedTech Solutions Inc. through Bounce Health Innovation.
We highly recommend PASB to entrepreneurs and innovators in the medical device industry. Their detailed regulatory assessment gave us a clear understanding of the regulatory requirements for our medical device in Canada and the United States. The templates and in-person training sessions provided by PASB on risk assessment and documentation requirements were incredibly valuable. They allowed us to gain insights that will help us develop medical device innovations well into the future. We are very impressed by the level of detail, guidance and continued support Sarah and Paul provide. We highly recommend PASB to other entrepreneurs and innovators in the medical device industry! Thank you so much for everything!!”
Allie Lynch, Founder, RAR Innovations
