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sdl3 started the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Hi,
I wanted to talk about something that come up occasionally at work. When I work on projects, I need to reference standards for various controls in the medical device market, like ISO, FDA, USP, AATB, ASTM, and others. However, I have noticed that in order to use them, the company has to purchase them and they are not cheap. You also don’t get…[Read more]
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sdl3 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
The ISO14971 regulation directly involves Risk management. A few of the requirements are to have risks identified and documented, a risk management plan, and risk control. These can be in the form of documents, policies, and procedures that the company must follow to ensure quality product is delivered to the customer and that employees are safe…[Read more]
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sdl3 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 8 years, 5 months ago
One thing, possibly less significant than many of the other suggestions here, is the difficulty in improving. If documentation is not done well and thoroughly from the beginning, it makes it difficult to improve later. Rationale and successful improvements cannot be made as easily when new employees cannot understand the reason for the previous…[Read more]
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sdl3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 8 years, 5 months ago
Coming from the “Continuous Improvement” mindset, I would think that the “snapshot” that EU regulatory bodies focus on is really only from a practicality standpoint. Each time the EU regulatory bodies perform an audit, they are looking for issues at that time, not necessarily from 10 years prior- though that’s not to say those documents are off l…[Read more]
