Thirty years of getting hard technology out of the lab leaves you fluent in a stack of standards most people only ever skim, and practiced at the product calls that decide what gets built. These guides teach both at full course depth, with one worked example per series and a written article beside every video. Live now: ISO 14971 risk management and product leadership.
In the queue
ISO 13485 quality management systems. IEC 60601 electrical safety for medical devices. The GHG Protocol and what Scope 1, 2, and 3 actually ask of a hardware company. Each one gets the same treatment: a full course, taught free.
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ISO 14971 and product leadership are the first two Operator’s Guides. ISO 13485, IEC 60601, and the GHG Protocol are in the queue. Leave your email and each new guide lands in your inbox the day it ships. Nothing else, no drip sequence.
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The courses are free. If you want help doing the product job, that’s the work I do.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →