– Clients –
We have worked with a variety of clients from small start-ups to large Fortune 500 companies. One of the benefits of Tabor Consulting is that we are fully versed in both quality systems and regulatory submissions so whether you are starting a medical device company from the ground up or integrating, Tabor Consulting can help you efficiently and effectively reach your goals in order to market your product while navigating the myriad of worldwide regulatory requirements.
QA/RA Consultant for artificial pancreas and diabetes applications.
TypeZero based at the University of Virginia is developing an artificial pancreas closed loop system on a cell phone to sense blood sugars and treat within insulin. They have over 25 successful clinical studies with the FDA. Tabor Consulting provided a complete quality system as well as regulatory guidance on strategy.
Testimonial: I’ve enjoyed working with Deanna on the building blocks of the QMS system. She is very knowledgeable about diabetes technology which makes it very helpful to discern a quality pathway for us. Molly McElwee-Malloy, Patient Engagement and Clinical Director, TypeZero
Process Validation and CAPA remediation
St. Jude Medical Neuromodulation develops technologies to help people affected by chronic pain and movement disorders through pacemaker like stimulation devices. Tabor Consulting helped in process validation and CAPA remediation.
Testimonial: "Deanna was highly skilled and knowledgeable in FDA compliance and CAPA standards. She was efficient and diligent in organizing and completing projects. I would recommend her for FDA medical device opportunities." James Carow, QA Manager at St. Jude Medical
IDE Clinical Study for CGM (Continuous Glucose Monitor) & Implementation of Quality System
Bayer iSense develops a continuous glucose monitor that tracks blood sugar levels day and night. It collects readings automatically every 5 minutes. Tabor Consulting developed a quality system and helped to write an IDE for submission to the FDA.
Testimonial: "I was the Site Director at Bayer Diabetes Deanna and hired Deanna as a consultant to help to write an IDE (clinical study) for a Continuous Glucose Monitor providing her regulatory expertise and mentorship. She also helped to develop an independent quality system. Additionally, I worked with her at Kimberly Clark where I was the R&D manager where she lead the design team in a highly visible project for an oxygentated wound dressing. She stepped into the role of technical design leader to provide design control guidance, leading meetings and overseeing the design of the product from feasibility through design transfer. She is personable, highly skilled in keeping abreast of regulations and has the benefit of being both versed in quality and regulatory in addition to her technical education in engineering to cross that bridge from R&D to compliance." Coni Rosati, Site Director Bayer iSense/Engineering Manager Kimberly Clark
Quality & Regulatory Consultant for patient monitoring including quality system procedures, CAPA and medical device reporting
VIDCO has been designing and manufacturing innovative products that provide remote patient monitoring, recording, storage, and other information management functions in all patient care environments.Examples include High-Risk Surgery, Emergency, Ambulatory, Telemetry, Cardiac Care, Intensive Care, Step-Down, Cath Lab and EP Lab and research facilities. Tabor Consulting has provided quality and regulatory support including, quality system procedures, licensing, representation at third party audits, e.g., FDA, Notified Body, CAPA’s, and Vigilance.
Testimonial: "Deanna, thank you the excellent job done. You got us through two full regulatory audits, and helped get our quality system up to par. You demonstrated all along the way, expert knowledge of regulatory requirements for ISO13485, ISO14971, and FDA reporting issues. I'd recommend you to anyone asking. "
Thank you, Darwin George Engineering and Compliance Manager, VIDCO
Pre-IDE for hemostatic medical device
RevMedx is dedicated to saving lives by creating groundbreaking medical products. They have devices designed specifically for combat medics and civilian first responders that will revolutionize the treatment of traumatic bleeding. Tabor Consulting wrote an IDE for their X-stat product.
Quality & Regulatory Consultant for dental devices including procedures, audits, technical files
Forest Dental designs and builds uniquely beautiful dental equipment for customers including delivery systems, charis, lights. Tabor Consulting has provided quality system and regulatory support including procedures and audit representation.