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Med-Tech Roundup

learn more about trends, news and advancements in the med-tech space

FDA Confirms Third-Party Entities Provide High Quality, Safe and Effective Servicing of Medical Devices

Posted by Charlotte Morello on Jul 9, 2018 9:58:30 AM

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. 

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Topics: Industry Advancements, Industry Trends, San Diego, CA, ISO Certification, Quality Management System, Medical Device Field Action, Medical Device Industry, Med-Tech Industry Update, Field Technical

Novasyte Achieves Ongoing "World Class" Client Satisfaction

Posted by Charlotte Morello on Jun 28, 2018 9:24:11 AM

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. 

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Topics: Industry Trends, San Diego, CA, ISO Certification, Quality Management System, Med-Tech Industry Update, Novasyte News

Novasyte Achieves ISO 9001:2015 Certification for Quality Management Systems

Posted by Charlotte Morello on Apr 4, 2017 4:02:00 AM

Today 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.

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Topics: Novasyte News, Quality Management System, ISO Certification