Community Forum
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Hot Topics
Understanding FDA Class I vs Class II Classification
I'm working on a new medical device and trying to understand the difference between Class I and Class II. Can anyone share their experience with the classification process?
Health Canada MDL Application Timeline
Has anyone recently submitted an MDL application? How long did the review process take? I'm planning my product launch timeline.
Software as Medical Device - Regulatory Pathway
We're developing a mobile health app that helps patients manage diabetes. Does this require FDA clearance? What's the best approach?
510(k) Predicate Device Selection Tips
Looking for advice on selecting predicate devices for a 510(k) submission. What factors should I consider?
Documentation Requirements for Class II Devices
Can someone provide a checklist of required documentation for Class II medical devices in Canada?
EU MDR Transition - Impact on Existing Products
We have products currently on the market under MDD. What do we need to do to comply with MDR?