YOUR PARTNER FOR INTERNATIONAL REGULATORY COMPLIANCE
MANAGEMENT, DEVELOPMENT & CONSULTING FOR MEDICAL DEVICES
Are you prepared for the IVDR?
NSF’s IVD App Coming Soon
The upcoming IVDR introduces major changes for manufacturers placing devices on the European market, including changes to device classification, requirements for technical documentation and clinical evidence, and new obligations for economic operators.
Take a look at some of our resources to help you prepare, they include a tool to compare IVDD and IVDR requirements, a white paper explaining IVDR safety and performance requirements and a webinar presenting preliminary templates for writing performance evaluation reports.
The best place to stay up to date with the latest IVD regulatory updates – access our library of free resources, contact our industry experts and enroll in our eLearning.
Are You Facing a Complexity Crisis?
Martin Lush explains the costs of over-complexity and the true root causes. It also includes a self-assessment questionnaire for you to discuss at your next team meeting.
Implementing a Simplification Strategy
This webinar from Jim Morris reviews three essential simplification strategies that site leadership and unit operations managers can pursue.
How to Jumpstart Your Pharma Business by Simplifying Processes
Making processes simple underpins GMP compliance as complexity is the catalyst for error and deviation. John Johnson shares how we use simple processes and a course toolkit to enable your team to begin the process of refinement, clarification and error proofing.
Fix SOP Complexity
In this short video, Martin gives his insight into how much detail we should put in a SOP to avoid overload, explaining what you should leave in and what to take out.
A Beginner’s Guide To Quality Risk Management (QRM)
The pharmaceutical industry approach to assessing and controlling quality risks has largely been empirical. This is often fine but in more complex or hazardous situations, the pharmaceutical industry could benefit from a number of very helpful tools and techniques.
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