Documentation is the Key to Development
Developing and manufacturing a medical device has an added layer of complexity that most innovators don’t need to worry about. The regulations and compliance requirements in life sciences (whether they be medical or pharma) are a massive undertaking. This is on top of actually creating the products themselves…which isn’t exactly easy. These rules are there for a reason, as the consequences of sending out bad product into the market is often life-threatening.
To manage this, a solid and trusted requirements and validation plan is required. In regulated industries, it needs to be built on top of GAMP 5 V-model; a specific engineering process for test & validation equipment. Here is an example of a starting point for reliable validation:
For any questions on medical device or pharma packaging questions, please contact Averna.
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