In May 2018, the FDA released a report titled "FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices," issued by the Secretary of Health and Human Services and in accordance with The Food and Drug Administration Reauthorization Act (FDARA). The FDA examined product servicing by manufacturers, healthcare establishments and third-party providers who refurbish, recondition, rebuild, remarket, service and repair medical devices.
Topics: Med-Tech Industry Update, Quality Management System, Medical Device Industry, Medical Device Field Action, San Diego, CA, Industry Trends, ISO Certification, Industry Advancements, Field Technical
The importance of providing and fearlessly seeking feedback at Novasyte goes back to the Company's inception in 2008. This cultural priority is not simply a theory discussed at the annual company meeting, but a living, breathing, organically-developed reality of the day-to-day environment that allows for cross-departmental synergies to develop, relationships to grow, and issues to be resolved in real-time.
Topics: Novasyte News, Med-Tech Industry Update, Quality Management System, San Diego, CA, Industry Trends, ISO Certification
**UPDATE as of March 2020: Novasyte's Quality Management Systems have been re-certified through March 2023. Download the ISO 9001:2015 Certificate here.
ANAB, an official accreditation body for ISO 9001:2015 standards, granted Novasyte ISO 9001:2015 certification for our quality management systems (QMS).
Globally recognized and respected, ISO standards are set by the International Organization for Standardization (ISO), a Geneva-based worldwide federation of national standard bodies. This certification demonstrates our dedication to and implementation of a systematic and quantifiable approach to quality-of-service standards through a rigorous auditing process.
Topics: Novasyte News, Quality Management System, ISO Certification
An IQVIA Company
Our VisionTo bring together the best-in-class people, technology and process to improve the lives of patients.
Our MissionTo become a premier, worldwide leader in delivering the full continuum of innovative outsourced solutions and positively impacting the lives of patients and end-users who work with our clients' medical device and diagnostic products.
Our Commitment
Everything we do is held to the highest standards in accordance with our ISO 9001:2015 compliant quality management system.
Awards
Inc. 5000 Fastest Growing Private Company Finalist 2019-2013
Ernst & Young Entrepreneur of the Year San Diego Regional Award Winner 2018
San Diego Business Journal Fastest Growing Private Company Finalist 2018-2015
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