Whether first time building or rebuilding, we are your source for quality management solutions customized to your needs. The Quality System Architects team is a highly trained and experienced team of Quality, Regulatory and Clinical professionals with over 20 years in the Medical Device Industry. We have extensive expertise and a proven record with building quality systems from the ground up, as well as process and product remediation under enforcement actions, including Consent Decrees.
We have extensive experience in the areas of QA/RA strategic planning, QA/RA organizational design and build out, quality system development/ implementation/improvement, inspection readiness, employee training, remediation under enforcement actions, change management and regulatory agency interactions. Our specific areas of quality system expertise include Design Controls, CA/PA, Complaint Handling/Adverse Event Reporting, Recalls, Training, Document Controls, Internal Auditing, and Management Controls.
Our team is actively involved in speaking engagements as well as course development and quality book publications.
We look forward to doing business with you.
Maria C. Cianciotto Scott T. Long
Principal Partners - Quality System Architects
Call today! (224) 217-1578
A Division of Wolf Enterprises, LLC - West Chester, Ohio 45069
Building Quality Foundations for Future Growth