Diapason Consulting

Regulations

Balance

A Quality Management System is often represented as a pyramid. Which is a relevant analogy. It has some “depth”, it is not a flat structure, and it matches well the hierarchical nature of many human thinking processes, of organisational structures, and of many information system paradigms (e.g. folders/subfolders). Consultants and other experts who use this analogy typically describe from 3 to 6 levels. All these options are valid. A QMS does not have - by essence - 3 or 4 or 5 or 6 levels.

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Regulations never sleep

Regs never sleep. And they can wake you up early. Early in the day and early in the startups life-cycle. When pitching for an early round, it’s tempting to think “Investors at this stage just need 1 slide or 2 to present our classification and a vague regulatory plan. In any case, they can always ask later, during the due diligence”. Experience proves that investors have done their homework:

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Just guidelines

I posted this as a Linkedin article - after I started a post and was out of room. After several instances of being temporarily banned from linkedin, I decided to safekeep it here. Nature is a continuous and multidimensional system. Any model based on a discrete classification will necessarily be a dimension-reducing projection, and will create arbitrary and energy-hungry distortions. Justin Kunimune, CC BY-SA 4.0, via Wikimedia Commons This article started as a comment to this post.

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Apple

Random Regulatory fact of the day: Apple is the sponsor of four medical devices in Australia. As expected, two are the two features of the Applewatch that are medical devices in Australia (registered in February and March 2021). Two others are gloves and infrared thermometers that Apple registered as importer at the start of the pandemic in early 2020. Technically, Apple started they #healthtech journey in Australia with thermometers and nitrile gloves.

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