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Articles

Disruptive Events: How Medical Device Companies Can Deal with Them Head on and Learn for the Future

Read the article below or download the complete PDF: "Don't Let a Crisis Become a Disaster" → When you hear “crisis,” you think “COVID.” But a…

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Articles – Video

Driving Innovation Through Changes to FDA Medical Device Regulations

The good news is that the FDA is enhancing review processes to ensure medical devices are safer and more effective. But are your new products…

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Articles

Steps to Accelerate Successful EU MDR Compliance

This article has been updated to indicate that the European Union Medical Device Regulation deadline has been extended one year, until May 26, 2021.  According…

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Articles

10 Tips for Leading Successful Medical Device Development Projects

Overseeing the development of a new medical device is a challenging undertaking. There are many moving parts involved in the process and risks and pitfalls…

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Case Studies

Optimized PPM Process Helps Medical Device Company Deliver Strategic Projects

The R&D team of a global medical device company was experiencing project slippage, diluted resources, prioritization problems, and too many projects within its current portfolio.…

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Case Studies

Beyond Compliance: Device Firm Reaps Benefits from Project Leadership

Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes…

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Case Studies

Successful Medical Device Design Transfer Lifts One of the Largest FDA Mandates in History

Project Background A global manufacturer received an FDA mandate on one of its medical devices to repair, retire, or replace all units (more than 200,000)…

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