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MedTech Roundup

learn more about trends, news and advancements in the MedTech space

Upcoming Speaking Event: Hillary Medina at AdvaMed's Medical Device Complaints, MDRS & Reports Workshop

Posted by Charlotte Morello on May 1, 2017 11:00:33 AM

We're excited to announce that our Director of Recall Business Development, Hillary Medina, will be speaking at the AdvaMed's Device Complaints, MDRs, and Reports Workshop in Washington, DC on Tuesday, May 23-24, 2017. 

Novasyte partners with med-tech companies, offering outsourced contract clinical, field technical and recall teams and services. Our cloud-based, S.M.A.R.T. Recall Program is an integrated, software and service-based solution to address the increasing challenges med-tech companies face when managing a recall. Our platform tracks every activity in real-time, including mock recalls, plan development, consignee notification, virtual or field-based product remediation, warehousing, and ongoing reporting.

Hillary's presentation, titled ""Communication Strategies for Recalls and Other Field Actions"will address the questions outlined below.

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Topics: Novasyte News, Medical Device Recall, Medical Device Recall Help

Novasyte Achieves ISO 9001:2015 Certification for Quality Management Systems

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

**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.

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Topics: Novasyte News, Quality Management System, ISO Certification

Upcoming Speaking Event: Tyler Tracy at the San Diego CFO Leadership Council

Posted by Charlotte Morello on Mar 29, 2017 4:28:20 PM

We're excited to announce that our Vice President of Finance, Tyler Tracy, will be speaking on a panel at the upcoming San Diego CFO Leadership Council meeting on Tuesday, April 18, 2017. 

The upcoming meeting titled, "Managing Through the Generations - What is Your Talent Management Development Strategy?" will cover the generational trends and strategies for managing a mix of Baby Boomers (1946-1964), Gen Xers (1965-1977), and Gen Ys/Millennial (1978 or later).

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Topics: Outsourcing Support, Novasyte News

Novasyte Announces 2016 Consultant of the Year

Posted by Charlotte Morello on Mar 21, 2017 11:47:54 AM

Today Novasyte announced Dan Cary, RT, as the 2016 Consultant of the Year. This acknowledgment is given to those consultants who continually strive to achieve the highest level of customer service to Novasyte’s med-tech clients. 

The Consultant of the Year award marks the highest form of recognition for consultants’ achievements in the field. Voted on by the internal Novasyte team, Dan was selected from four high-performing consultants nominated Consultant of the Quarter, who were in-turn recognized among the 52 individuals awarded Consultant of the Week. Client feedback, number of hours worked, expense management performance, and tenure with Novasyte are the key contributing factors evaluated when awarding Consultant of the Week.

“I was genuinely surprised,” said winner, Dan Cary. “It was absolutely the last thing I expected. The other Consultants of the Quarter were such strong contributors, and as a respiratory therapist, I was certain an RN would win. I just feel very grateful and hope my appreciation comes across.”

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Topics: Novasyte News

Novasyte Announces New Service to Address Unmet Need in Med-Tech Industry for Recalls

Posted by Tim Gleeson on Feb 15, 2017 4:45:00 AM

Today we're excited to announce our new service offering - S.M.A.R.T. Recall Program.

Providing closed-loop management for FDA recall, correction and removal support, we now support our med-tech clients by managing all levels of field actions in our cloud-based system – from software upgrades, to stock recovery, market withdrawal, and Class I, II and III recalls.

Conceptualized in early 2013, the S.M.A.R.T. Recall Program was developed in response to the growing challenges med-tech companies face when managing medical device recalls internally. A deviation from their core competency of manufacturing and selling, med-tech companies are facing increasing pressures around quick mobilization, scalability, and systems integration when working with paper forms, fax returns, and spreadsheets. Further, they are challenged to accurately track per-unit activity in real-time to meet their FDA reporting needs.

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Topics: Novasyte News