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.
**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.