<img height="1" width="1" style="display:none;" alt="" src="https://dc.ads.linkedin.com/collect/?pid=311073&amp;fmt=gif">

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. 

Read More

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. 

Read More

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

Landmark CA Supreme Court Ruling Determines Hiring W-2 Employees over 1099 Contractors is Crucial to Mitigating Employer Risk

Posted by Sam Elbaz on Jun 6, 2018 10:18:52 AM

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.

Read More

Topics: Industry Trends, San Diego, CA, Medical Device Industry, Med-Tech Industry Update, Novasyte News

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.

Read More

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

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.

Read More

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

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.

Read More

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

Strategies for Maintaining Accurate Consignee Recall Data

Posted by Charlotte Morello on Dec 12, 2017 4:16:12 PM

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.

Read More

Topics: Medical Device Recall Help, Medical Device Industry, Industry Advancements, Industry Trends, Med-Tech Industry Update, White Paper, SMART recall program

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.

Read More

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

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.

Read More

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