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	Bridging the Gap Between Users Needs and Design Inputs By JacobChabuel 2 months ago \| Last Post: 2 weeks ago Forum Introduction to Design Controls
	Criteria definition with consultation of the targe... 2 weeks ago By rgall... The best way to translate a qualitative user need ... 1 month ago By jacob... I would argue that structured frameworks are the o... 1 month ago By James... view all posts
	Updating documentation or information overload? By ATMEH.NJIT 2 months ago \| Last Post: 2 weeks ago Forum Introduction to Design Controls
	I think balance comes with a clearly defined purpo... 2 weeks ago By rgall... Organizations can balance the need for up-to-date ... 1 month ago By jacob... Everyone’s shared great technical solutions, but a... 1 month ago By shrey... view all posts
	Efficiency or Compliance? By ATMEH.NJIT 2 months ago \| Last Post: 2 weeks ago Forum Introduction to Design Controls
	I believe companies do treat design controls as a ... 2 weeks ago By rgall... I think many companies initially treat design cont... 1 month ago By James... Following design controls intentionally is importa... 1 month ago By pz98 view all posts
	When Mitigation Becomes Its Own Risk! By ATMEH.NJIT 1 month ago \| Last Post: 2 weeks ago Forum Risk Analysis for Medical Devices
	The addition of new risk controls will almost alwa... 2 weeks ago By rgall... Risk controls go too far when the new complexity, ... 1 month ago By jacob... One thing which I think is also important to consi... 1 month ago By pz98 view all posts
	Are We Over-Relying on FMEAs? By ATMEH.NJIT 1 month ago \| Last Post: 2 weeks ago Forum Risk Analysis for Medical Devices
	FMEAs are critical in understanding the predictabl... 2 weeks ago By rgall... FMEA is useful, but it can create a false sense of... 1 month ago By jacob... To build upon what was mentioned in the post befor... 1 month ago By pz98 view all posts
	Can Risk Really Be Eliminated — or Only Managed? By ATMEH.NJIT 1 month ago \| Last Post: 2 weeks ago Forum Risk Analysis for Medical Devices
	In the ideal world, I think absolute 0 risk would ... 2 weeks ago By rgall... In medical devices, the goal can never realistical... 1 month ago By jacob... I agree that eliminating risk entirely is not real... 1 month ago By Sky_H... view all posts
	When and How Should Engineers Speak Up to Leadership? By NaomiAlves 1 month ago \| Last Post: 2 weeks ago Forum Organizational Development in Device Companies
	I think the optimal way to speak up about an issue... 2 weeks ago By rgall... Something I think doesn’t get talked about enough ... 4 weeks ago By shrey... I agree with the points raised by everyone so far.... 1 month ago By Dev D... view all posts
	Design Controls vs Project Management — Why Do We Keep Mixing Them Up? By ATMEH.NJIT 1 month ago \| Last Post: 2 weeks ago Forum Organizational Development in Device Companies
	I think the main gap between design controls and p... 2 weeks ago By rgall... I think a big reason teams struggle to connect Des... 4 weeks ago By shrey... I think a key issue in integrating Design Controls... 1 month ago By Dev D... view all posts
	Leadership or Management — What Drives Better Teams? By ATMEH.NJIT 1 month ago \| Last Post: 2 weeks ago Forum Organizational Development in Device Companies
	I believe the determining factor to this discussio... 2 weeks ago By rgall... Another important factor is the extent to which th... 4 weeks ago By shrey... I think the best team outcomes in medical device d... 1 month ago By Sky_H... view all posts
	How “Modest” Should Gifts to Physicians Really Be? By ATMEH.NJIT 4 weeks ago \| Last Post: 2 weeks ago Forum Consultants and Legal Basics
	I find the $100 dollar a gift limitation to be ext... 2 weeks ago By rgall... Loopholes will always exist in every area where th... 3 weeks ago By pz98 I think the real issue with defining what “modest”... 3 weeks ago By Dev D... view all posts

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