Vanguard Engineering & Consulting Group

04/20/2019

https://www.thomasregulatory.com/l/fda-rule-change-from-21-cfr-820-to-iso-13485-2016-harmonization-for-quality-systems-and-audits/

FDA has formally announced its intention to transition away from the Quality Systems Regulation (QSR) per 21 CFR 820 and transition to the ISO 13485:2016 for its audit inspections of medical device manufacturers. The new rule could be released as soon as mid 2019 and will roll out over the next few....

02/01/2019

https://www.inc.com/magazine/201309/jessica-bruder/psychological-price-of-entrepreneurship.html

No one said building a company is easy. But it's time to be honest about how brutal it really is -- and the price so many founders secretly pay.

01/23/2019