Data integrity issues continue to impact drug and device companies in increasingly complex ways.

The sophistication of data environments in the digital age has made auditing as critical as it is difficult. These assessments demand a lot from auditors, and the breadth of systems in need of assessment can present daunting risks when auditors fail to assess all areas in need of review, leaving their organization vulnerable to serious problems.

Whether you're establishing a data integrity auditing program for the first time or simply need to improve your current audit strategy, we've summarized some key concepts to consider each step of the way.

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February 22, 2018

MDR vs. MDD: 13 Key Changes

Europe's new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization.

As companies begin planning their transition program to bring their organizations into compliance under the new Regulation, it's important to be aware of all the major changes that will require planning and action.

The video below is a snippet from our recent free webinar, The Complete Guide to EU-MDR Transition. In the full webinar, we highlight the key parts of the MDR, while going a step further to present a step-by-step MDR transition process that can be adapted to suit your company's unique needs.

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It's a question that, even after careful consideration, can seem difficult to answer: Does the FDA actually "require" medical device manufacturers to perform risk analysis? If so, where?

The short answer is yes. But the topic requires a more nuanced discussion. We've summarized where the confusion stems from and how and where regulators require risk analysis below.

 

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The release of the Medical Device Regulations (EU-MDR) has put significant pressure on medical device companies to closely scrutinize the new regulations, assess the impact on their own organization, and implement compliant processes and procedures accordingly.

As important deadlines approach for implementing the final version of the EU-MDR, medical device manufacturers should be focused on planning and implementing their transition program now.

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