@jonwil123 You made some good points about the differences between Quality Assurance and Quality Control. The Quality Assurance team is needed to make sure that there are smooth transitions between the planning phase. The planning phase of a project defines…   Read more»

I would have to agree with @jonwil123 here. I see the importance in having the 501K approval for some devices that have proven enough clinical significance as an old one. Perhaps the same company that released the device 40 years…   Read more»