design controls | Compass | 21 CFR 820.30 | EU MDR
Imagine developing a medical device or drug that could be claimed to work without any evidence….
requirements | design controls | 21 CFR 820.30
There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and external customer requirements, to name a few. Finding harmony and documenting everything is not a simple paperwork exercise. This can be overwhelming to even the most seasoned medical device professional. How do you make sure the user needs are linked to actionable requirements, and ensure that all requirements have been addressed?
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