– 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. Tabor Consulting provides comprehensive regulatory and quality solutions for its clients, from regulatory submissions to the ground up quality systems, or can provide knowledgeable support for specific projects on an as-needed basis. Whether you are developing a new product, improving an existing product, or simply trying to comply with the myriad of regulations and standards, Tabor consulting will accelerate your success and profitability. We accomplish this through a combination of core competencies including:
Quality Systems
Development:
Mt. Tabor Consulting has developed Quality System compliant to the FDA and ISO 13485 MDSAP from the ground up at smaller companies as well as integrated systems at Fortune 500 companies. No matter the size of your business, whether you have an electronic QMS, Tabor Consulting can work with you to streamline a system that is efficient and effective.
Regulatory Submissions:
Mt. Tabor Consulting has experience with FDA and worldwide submissions including CE Mark and Canadian Licensing. Our experience includes Class III medical devices.
Design
Control:
Mt. Tabor Consulting has procedures and has lead design control and development teams including those software based from feasibility to commercialization including documentation of inputs, outputs, risk assessment, verification and validation, and transfer.
Compliance Assessments & Audits:
Mt. Tabor Consulting is ISO 13485:2016 MDSAP trained in internal audits and has performed many on-site internal audits for clients as well as representing clients during their audits with third parties (e.g., FDA, Notified Bodies, UL, etc.)
Compliance Remediation Specialties include, but are not limited to Class III implantable devices - FDA, MDR, CE, Canada submissions; FDA submissions and face-to-face meetings, Quality System Development (ISO 13485 MDSAP and cGMP), Process Validation (Installation/Operational and Performance Qualifications; Design Control; Product Development; Auditing; Risk Assessments; Corrective Actions; Complaints; Supplier Quality.