HIT Consultant July 31, 2025
In the past five years, medical device companies have faced continuous change, with new regulations, evolving standards, and increasing documentation requirements. The 2024 MTI Regulatory Report put it plainly: “time and bandwidth” have now overtaken cost as the biggest challenge for regulatory affairs teams.
This shift points to a deeper issue. The volume and pace of regulatory change have outgrown traditional compliance approaches. Tracking updates and reacting as they come is no longer enough. By the time a new guidance is reviewed, its impact may already be shaping audits, delaying market access, or forcing design changes.
Compliance today demands more than awareness. It requires regulatory intelligence: a structured, contextual, and forward-looking approach to understanding change and acting on it before...
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