I agree with others that the Design History File (DHF) is a living document. The FDA states that ” the DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a…[Read more]

I think management should already have a good understanding of the resources needed to uphold their QSR. As we learned this week in lecture Management oversees the subsystems: i. Design Controls, ii. Corrective and Preventative Actions, iii. Production and Process Controls, iv. Equipment and Facility Controls, v. Records Documents and Change…[Read more]

For one of the company’s projects, myself and other colleagues had to sign an NDA regarding the project circumstances and to not disclose information or penalties will be enacted. Before signing, we had a small forum to discuss and deem what was allowed and not allowed which I would greatly advise ensuring compliance. Now, whether it is obvious to…[Read more]

I agree with @bb224 and @asimbana that for a medical device company of mid-size with 50 people and $10 million in revenue they should be an Inc so they have the ability to go public and spark some interest and attract investors (VCs, etc). The company should be incorporated in Delaware since they have more favorable corporate and tax laws. As @thu…[Read more]