Harmonizing Quality Management

Harmony and the FDA… 🎶 🎸 🎷

It creates a pleasing effect when things work together. 😌

Harmonization not only applies to music, but also when regulations are tuned to work together. This occurs when a regulatory agency, like the FDA, modifies its regulations to “align more closely with [an] international consensus standard.” (FDA)

In February 2022, the FDA announced they would be “incorporating by reference the 2016 edition of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485.” (FDA)

They set a timeline to harmonize quality management standards with ISO 13485 by December 2023. 🥳 🤓

This is a big deal. 👍

Why? 🤔

Harmonizing quality management regulations eliminates duplicity in the regulatory process for digital health apps and other medical devices.

This will save time and money, both for US companies going global and global companies entering the US. 🌍 🇪🇺 🇺🇸

Furthermore, it can especially help European and German-based startups gain regulatory approval faster, avoiding the notified body logjam under MDR and going directly to the US, without having the burden and cost to refactor their quality management documents.

While this is good, it is just a start. More efforts are needed to align various regulatory agencies to make the process of bringing a medical device to market more efficient.

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