What Pathmaker clients are saying about their experience
“In each of the varied regulatory challenges on which Amy and her team have worked with me, they have been strategically essential, and tirelessly dedicated to technical excellence. Working in the space of novel digital medicine products, we often don’t have regulatory precedent to rely on, so creativity and trust building with healthcare authorities is essential; this team brings that in droves.”
Dan Karlin, MD, MA
CMO, MindMed
“Amy Fowler and her team have been a trusted partner for our Company for over 5 years. Our focus on innovation of novel surgical and medical devices creates a need to understand the options and ultimately the best strategic direction for new product registration. Pathmaker FDA always works closely with us to understand our products and objectives and provides sound direction for our regulatory decisions. The firm has been an invaluable resource for us when we are challenged with interpreting regulations, guidelines and then ultimately selecting the course for our technology.”
Brian Tippett, MD
President and CEO, Plasma Surgical Inc.
“Pathmaker has been a valuable partner in guiding us whenever our products intersect with regulatory issues and the FDA.”
Jim Strickland
CEO, Thayer Medical
“It is my privilege to recommend Amy Fowler and Pathmaker FDA Law. Amy’s deep knowledge and longstanding relationships with the FDA have proved invaluable for MGC Diagnostics. With Pathmaker’s representation, we successfully brought numerous products to market, and most notably, successfully lead MGCD through a 510(k) appellate process. I strongly recommend Amy and the team at Pathmaker for all your FDA requirements.”
Todd Austin
CEO, MGC Diagnostics
“Amy and her team have been an invaluable resource for Garreco Dental LLC:
– She has managed a team of experts to provide services, technical documentation, biocompatibility studies, risk management, and regulatory compliance for the allowance of medical grade wax into the EU market
– Assisted over the years in providing regulatory guidance with topics including medical device shelf-life expiratin, state medical device registrations, FDA mandated universal device identification, and California Prop 65 compliance.
– Provided guidance in the development of the ISO/FDA required preservation of product processes.
– Assisted in the evaluation of electronic QMS software system used to manage quality assurance.
– Currently provides personnel to conduct annual ISO/FDA required internal audits of the QMS.
– Aided in developing Quality Agreements used to hold vendors accountable.
– Assisted in the review of Quality Agreements delivered by customers.”
– She has managed a team of experts to provide services, technical documentation, biocompatibility studies, risk management, and regulatory compliance for the allowance of medical grade wax into the EU market
– Assisted over the years in providing regulatory guidance with topics including medical device shelf-life expiratin, state medical device registrations, FDA mandated universal device identification, and California Prop 65 compliance.
– Provided guidance in the development of the ISO/FDA required preservation of product processes.
– Assisted in the evaluation of electronic QMS software system used to manage quality assurance.
– Currently provides personnel to conduct annual ISO/FDA required internal audits of the QMS.
– Aided in developing Quality Agreements used to hold vendors accountable.
– Assisted in the review of Quality Agreements delivered by customers.”
Bob O’Neal
CEO, Garreco Dental LLC