White Paper

Supplier Quality Management: A Summarized Approach

Supplier Quality Management: A Summarized Approach

Want to learn more about the importance of effective supplier controls and management in the context of medical devices? You’re in the right place! This White Paper covers the different aspects of supplier quality management including: the fundamental role of...

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Benefits of Decentralized Clinical Trials

Benefits of Decentralized Clinical Trials

Want faster, more diverse subject recruitment for your clinical trial?  Or are you interested in running a trial utilizing digital health technologies? If yes, then a Decentralized Clinical Trial (DCT) might be right for you! There are many steps and parts to complete...

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Top Risks for Large Language Models

Top Risks for Large Language Models

Transforming the landscape of artificial intelligence, Large Language Models (LLMs) such as ChatGPT and Bard (a conversational generative artificial intelligence chatbot developed by Google) have taken center stage, captivating many industries with their immense...

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FDA “Voluntary” (For NOW) eSTAR Program

FDA “Voluntary” (For NOW) eSTAR Program

You NEED the FDA eSTAR Quick Guide! Who remembers when Microsoft Office first came out? Everyone was learning and an Excel or Word laminated cheat sheet could be bought at the grocery store to help with the learning curve. This eSTAR White Paper has a similar intent,...

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Design Control: From Evolution to Commercialization

Design Control: From Evolution to Commercialization

Are you in the early stages of design development of a product? Or do you need help remediating your Design History File? This White Paper will provide guidance on the global requirements of design control and the documented evidence needed to meet global regulatory...

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