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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: 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

Insourcing vs. Outsourcing Your Recall Management Strategy

Posted by Charlotte Morello on Jan 3, 2018 4:31:00 AM

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.

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Topics: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper

Do Not Let the Spreadsheet be the Database – Centralize It

Posted by Charlotte Morello on Dec 19, 2017 4:32:00 AM

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.

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Topics: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper

Develop a Methodical Approach for the Field Strategy

Posted by Charlotte Morello on Dec 14, 2017 4:31:00 AM

 

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.

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Topics: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper

Current Recall Landscape in the Med-Tech Industry

Posted by Charlotte Morello on Dec 7, 2017 4:32:00 AM

 

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.

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Topics: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper

Recall Case Study: Achieving FDA Compliance in an Average of 10 Weeks

Posted by Charlotte Morello on Dec 5, 2017 4:32:00 AM

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.

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Topics: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper