MedDev Compliance, LLC was founded on the principle that quality system compliance is a byproduct of straightforward and easy to follow processes. The tendency after receiving an unfavorable audit report is to become more stringent and prescriptive in addressing quality or compliance problems. Our experience has shown that more complexity in a process or a design does not always result in improved compliance or quality. Our approach will always be to take a step back and look for ways to simplify and streamline your processes.
Founded by Steven Mounts, a 25 year veteran of the quality assurance and regulatory affairs profession. With over 20 years of experience directly interacting with FDA officials at the district and headquarters level, Mr. Mounts has extensive knowledge of problem resolution in response to Deficiency Letters, 483 Observations, Warning Letters and Consent Decrees.
Having held positions in nearly every area of Quality Assurance including Quality Engineer, Inspection Supervisor, Plant QA Manager and Vice President of Quality Assurance, Mr. Mounts has obtained practical, working knowledge of how to create, implement and maintain effective, compliant quality systems. He has extensive experience with international and domestic regulatory topics concerning class I, II, and III medical devices including: supply chain quality, design control, validation, risk assessment/management, product complaints and MDRs/MDD Vigilance reporting.
Mr. Mounts is an ISO lead auditor of quality systems and has conducted over 100 supplier and internal audits. He has also hosted and/or participated in over 40 FDA, notified body and regulatory agency audits/inspections. He also has extensive experience in S/W validation and electronic records compliance, responsible for overseeing the validation of over 900 S/W applications.
An accomplished speaker, Mr. Mounts has presented and provided training to employee groups, industry peers and FDA officials on numerous occasions for such topics as Process Validation, S/W Validation, Managing FDA Inspections, CAPA, Complaint Handling, Reducing In-Process Inspection, and Defensive Writing for Quality Records.
Mr. Mounts obtained a Bachelor of Science degree from California State University-Fresno in Industrial Technology, with an emphasis in Manufacturing Automation.