Medical Device Courses | thuytienlecao | Mentions https://medicaldevicecourses.com/members/thuytienlecao/activity/mentions/ Activity feed mentioning thuytienlecao. Fri, 24 Apr 2026 18:57:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 995fa678b0b8e9ef43f9b7faddf3b4e7 alexandrabuga replied to the topic Discussion Topic: Is the DHF a living document? in the forum The Design History File https://medicaldevicecourses.com/activity/p/7642/ Sun, 06 May 2018 22:10:16 -0400 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]

]]> 0 d135322c13ca2f662479942c6792cc85 alexandrabuga replied to the topic Management Responsibility in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/7183/ Sun, 08 Apr 2018 22:54:40 -0400 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]

]]> 0 2158abda4d6bb8e044cab8eb8d2f9b03 hc255 replied to the topic Advice before signing an NDA in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5437/ Sat, 02 Dec 2017 15:43:52 -0500 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]

]]> 0 84fe0fdc0c99d16c5448d00fd998523d alexandrabuga replied to the topic Discussion Topic: Inc. vs. LLC in the US in the forum Business 101 https://medicaldevicecourses.com/activity/p/4071/ Fri, 13 Oct 2017 02:49:17 -0400 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]

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