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: 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
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: Industry Trends, San Diego, CA, ISO Certification, Quality Management System, Med-Tech Industry Update, Novasyte News
On April 30, 2018, the California Supreme Court unanimously ruled to establish clearer distinctions between W-2 employees and 1099 independent contractors. Additionally, they made the process more difficult for employers to classify an employee as an independent contractor through an updated, more restrictive "ABC" test.
Topics: Industry Trends, San Diego, CA, Medical Device Industry, Med-Tech Industry Update, Novasyte News
Organizations who have previously struggled with managing a recall internally, or perhaps do not have the time or resources to maintain the consignee data, develop a field strategy or create a centralized database, can trust Novasyte as their recall management partner.
Topics: White Paper, Industry Advancements, Industry Trends, Med-Tech Industry Update, Medical Device Industry, Medical Device Recall, Medical Device Field Action, S.M.A.R.T Programs, SMART recall program
It is easy to fall into the rhythm of receiving multiple spreadsheets from various sources – be it sales, regulatory, marketing or quality – and by having them in one place, feeling like the recall is “under control.” In working with more than half of the largest med-tech companies globally, Novasyte has discovered this is a common theme.
Despite the commonality of this approach, there are inherent associated risks with managing a recall across multiple spreadsheets. Here are the top four.
Topics: White Paper, SMART recall program, S.M.A.R.T Programs, Industry Advancements, Industry Trends, Med-Tech Industry Update, Medical Device Field Action, Medical Device Recall, Medical Device Industry
Prior to launching a field team to address the product need, it is critically important to assess the effectiveness of the field strategy as it could result in a significant, potentially unnecessary, budgetary hit.
Topics: White Paper, Industry Advancements, Industry Trends, Med-Tech Industry Update, Medical Device Field Action, Medical Device Industry, Medical Device Recall, SMART recall program, S.M.A.R.T Programs
This is never as simple as it sounds, and it may even sound obvious. That said, it is one of the critically important steps to ensuring a recall is executed accurately and timely.
Topics: Medical Device Recall Help, Medical Device Industry, Industry Advancements, Industry Trends, Med-Tech Industry Update, White Paper, SMART recall program
Product recalls happen. Even to the most diligent organizations.
With the medical device landscape continually evolving, organizations must be agile and ready to respond to a recall at any moment. In looking at the annual number of medical device recalls in the graph below, one thing is known - recalls are not going away.
Topics: White Paper, SMART recall program, S.M.A.R.T Programs, Medical Device Recall, Medical Device Field Action, Medical Device Industry, Med-Tech Industry Update, Industry Trends, Industry Advancements
A global healthcare organization had multiple nationwide recalls with over 1.8 million units in 2,500 facilities. Facing internal bandwidth constraints, Novasyte was hired as the partner-of-choice to manage the recall execution.
Topics: White Paper, Industry Trends, Industry Advancements, Med-Tech Industry Update, Medical Device Field Action, Medical Device Recall, Medical Device Industry, SMART recall program, S.M.A.R.T Programs
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 2018-2013
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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