About Cherry Tree Quality Consulting

• 30 Years Experience Managing Quality and Regulatory

• Medical Device experience includes ophthalmic, orthopedic/spinal, IVD, combination products, radiation oncology, patient monitoring, and infusion pump devices

• Regulatory Experience includes Global Device Registrations, 510(k) submissions, IDE/Clinical Trial protocols, FDA AI Responses, NSE Appeals, 483 Responses, Recalls, Safety Assurance Cases, and Warning Letter Responses

• Demonstrated strengths in establishing and continually improving Quality Management Systems

• Experienced with FDA QSR/QMSR, ISO 13485, EU MDR, Canadian CMDR, MDSAP, Korean FDA, and ISO 9001

• Degrees: BSME and MSE from the University of Central Florida

• Active in Standards: TAG 176 and PC 302; Involved with Updates on ISO 9001 and ISO 19011