Tackling Go-To-Market Challenges The medical device industry is amid an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is issued somewhere in the world. All told, this amounts to 22,000 new or updated regulations every year, and it has led to a 150% increase in regulatory mandates over …
Risk Management Is More Than a Spreadsheet In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we will look at how a change from a document-driven risk management approach to a data-driven risk management approach can help mitigate product failure. Mitigating risk …
BlackHägen Design Expands Its MedTech Research and Design Capabilities BlackHägen Design, a multidisciplinary, user-research and product design firm, is expanding its staff expertise in the medical device arena in the areas of Industrial and User Experience (UX) Design, Human Factors, Mechanical and Software Engineering. The expansion is in response to new requirements for the …
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White Houses Releases AI Bill of Rights Blueprint Against a backdrop of growing concern surrounding biased data and rights to privacy and informed consent, the White House has released the “Blueprint for an AI Bill of Rights” that lays out five principles and associated practices to protect the American public against potential harm. “Among …
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