Hi All,
As Dr.Simon mentioned about Tech file:
It is a Comprehensive collection of information and documents, Contains Details everything about a medical device, Less complex for MDD Class I and more complex for the others.
A technical file is much closer in nature to a 510(k) than a design history file; it’s basically the European version of the 510(k). It is required to get your device into Europe and several other parts of the world.
According to this week lecture and what we have learned in the last semester, what do you think about Tech file & 510k, differences and similarities, which one easier to submit?

For example:
It is easier to change things in Tech file and contact Notified Bodies (NBs) with any change.
Also, one big difference with a technical file versus a 510(k) submission is the need to provide a clinical evaluation report. A clinical evaluation report addresses the product’s clinical investigation, risk, and outlines any post-market clinical follow-up studies that may be necessary.