– Welcome! –
Tabor Regulatory & Quality Consulting, LLC.
We specialize in regulatory compliance and quality assurance consulting.
Please contact us if you are looking for an experienced specialist.
ABOUT
Deanna has extensive worldwide regulatory and quality experience in medical devices including class III implantable devices. She has experience in the areas of ophthalmology, cardiovascular, neurological, diabetes, dentistry, and wound care, including software.
SERVICES
Tabor Regulatory & Quality consulting is a regulatory compliance and quality assurance consulting and process outsourcing company. Serving the medical device industry, Tabor Consulting's clients range in size and scope from small start-ups to large multi-national companies.
MOST RECENT POST
MORE INFORMATION?
Mt. Tabor Consulting is all your regulatory and quality compliance needs in one company.
We offer worldwide submission experience including Class III FDA regulated products, CE Mark, Canadian Licensing, building Quality Systems from the ground up as well auditing assistance and remediation in the medical device and biotechnology sectors.
WHY?
In this age of the quantifiable self with medical devices being offered on phone and tablet applications like continuous glucose monitoring to brain simulations, whatever your medical device application, Tabor Consulting can help you navigate the myriad of regulations while you can stay focused on development and operations. With 20 years of experience in the medical device compliance field, let us help you get your product to market as quickly and efficiently as possible.
WHERE ARE WE?
WHY IS THIS IMPORTANT?
Mt. Tabor Consulting is located in the beautiful silicone forest of the Pacific Northwest of Portland, OR. Portland, Oregon is one of the most moved to cities as of late providing a burgeoning technology and development workforce on the forefront of medical device applications. Most our work can be done remotely, but we are happy to come to you with easy access to an airport and closeness to biotechnology companies and hubs on the west coast.
WHAT ARE OUR SPECIALTIES?
Mt. Tabor Consulting is versed in worldwide quality and regulatory compliance including ISO 13485:2106 MDSAP, Certified Internal Auditing to ISO 13485/9001; MDR including Clinical Evaluation reports, PMCF, PSUR, CE Design Dossiers/Technical Files; UDI Labeling, IEC 60601-1 Ed. 3, Design Control, Software Development Life Cycle to ISO 62304, FDA, CE, Canadian submissions; Process Validation (IQ/OQ/PQ) and statistical sampling; Interfacing with regulatory agencies (FDA & ISO) -real-time FDA submissions, FDA face-to-face meetings, third party audit representation; Vigilance, Corrective and Preventive Actions (CAPA), and addressing FDA 483’s.
OUR DEDICATION TO YOU
With over 20 years of experience in worldwide quality systems and submissions, Tabor Consulting is dedicated to providing you with the Quality and Regulatory services
while speedily getting your medical device to market, simplifying the burden of the myriad of regulations imposed by the FDA, EU, Health Canada, the TGA, JPL, etc.
