Design Control for Medical Devices - Online introductory course

This is a short course on design control for medical devices. The goal is to give you a basic understanding of what design control is.
The short course is also a preview of the full online course: Introduction to Design Control for Medical Devices which is available at:
medicaldevicehq.com/design-co...
Chapters:
00:00 About the instructor
00:14 Introduction to the short course
00:37 Learning goals
01:08 What is design control for medical devices?
01:24 Why you need to understand design control requirements
01:50 Why you should do design controls for medical devices
03:00 Understand the industry-specific language
04:08 What is intended use or intended purpose?
05:30 What are user needs?
05:48 Translate user needs to design input
06:52 Design verification is a regulatory requirement
07:38 Design validation s a regulatory requirement
08:34 Competent authorities in the EU and the US
09:15 Notified bodies audit medical device manufacturers
09:55 Summary of key medical device development terms
10:14 The project management process phases
16:40 Additional help and resources

[@ancientmagi8354]

After working in medical device industry for three year, I can say that this video is awesome! It contains great basic knowledge in an overview style that's easy to understand where each piece falls into place. As well as the clearly defined terms and it's usage. When watching this video, think of yourself designing a product, and this will help make this video even more relevant to you as it already is. Thank you for the good work, please keep it up!

[@MedicalDeviceHQ]

Thank you so much!

[@Progamer97531]

Hi can u plz help me about medical device design control by giving me an example of any specific medical device
Thanks

[@wtsg1982]

Something that I can relate to my daily work in a non medical industry, there is slight difference which is necessary for me to know how medical industry actually design and release a product.
Looking forward for more videos of same quality in terms of coverage and depth!

[@ankitkaushik7531]

Very clear thought process and delivery!

[@mohanbhatsingapore4929]

Excellent and clear way of Presentation of Deign Control. Thank you

[@marcochimio]

Absolutely beautiful "30,000 foot view" of the Design Control process. Thank you.

[@petersebelius6886]

Thanks for the feedback and for commenting.

[@seanledesma5997]

I'm currently a QC specialist in the pharmaceutical industry, and looking to apply for a Senior QA specialist position at another company and have been learning so much from watching your videos, learning about all of the regulations pertaining to the position. I'm glad I found this channel, thank you!

[@Adrian-hx6dq]

As a mechanical engineering student I found AWESOME this explanation of V&V process. I am working at a manufacturing plant of medical devices ans this help me to understand why do we care a lot about quality and regulatory affairs. Big thanks from México!

[@MedicalDeviceHQ]

Thank you Adrian. Much appreciated. If you liked it, make sure to share it with your colleagues or in your LinkedIn network. That will be much appreciated. Or why not following Medical Device HQ on LinkedIn! Cheers!

[@ipekkutlu78]

Thanks so much! Really good content 👌

[@KarandeepBadwal]

Excellent Summary Peter!

[@MedicalDeviceHQ]

Thanks for the feedback! :-)

[@timmytab2836]

Excellent short course

[@subravetipavankumar1293]

One of the best lecture about design controls

[@MedicalDeviceHQ]

Thanks for the kind words!

[@coastalfamily]

Excellent intro. Very much appreciated.

[@MedicalDeviceHQ]

Thanks for the kind words!

[@afaquekhan2271]

Thanks for video ! Very informative !

[@MedicalDeviceHQ]

Glad it was helpful!

[@aniawo5119]

I have been working in Medical Device company for 2.5 years and only starting to grasp the basics aspects of product decelopment thanks to your video. Thank you very much.

[@MedicalDeviceHQ]

Thank you for the kind words.

[@darkwizard818]

Great work!

[@MedicalDeviceHQ]

Thank you! Cheers!

[@sanketmane7109]

Thank you🙂

[@namratha.g.r.6801]

Very useful video, especially for people who are in medical devices and very new to it ....

[@MedicalDeviceHQ]

Thank you for the kind comment!

[@namratha.g.r.6801]

@@MedicalDeviceHQ Sir, I work for Becton Dickinson and would like to learn more about medical industry. It'll be really helpful if you can guide me and provide me insights.... Thanks in advance, Namratha

[@rukmanandhan4913]

Thanks sir...

[@MedicalDeviceHQ]

Thank you for watching!

[@wolfdd.5718]

It's same biomedical engineering?

[@davidbrooks6452]

Very informative. However the product development process appears very waterfall. Any thoughts on applying the process in an agile setting?

[@MedicalDeviceHQ]

Hi David, it is indeed a lot of waterfall model in this video. The requirements on design control can basically be applied to just about any development process you select, it is just more or less challenging. And there are few reasons to implement agile if you are not working with software. Most manufacturer that work with embedded software would apply an hybrid model. If you would like to learn more about software, check out CHristian's video or his course on Software for medical devices. medicaldevicehq.com/introduction-to-software-for-medical-devices-and-iec62304-online-course/

[@MTB_Rider_96]

can a product made up of two 510k cleared medical devices and no biologics or drugs be classified as a combination device?

[@santhoshnaik1431]

Best medical devices certification websites for short duration

[@meghabisht4666]

Material selection is challenging

[@jacekc6179]

Sorry, but its was not very useful. Maybe you should speak finnish.

[@MedicalDeviceHQ]

Jacek, if you want a video in Finnish, I recommend you to look for that. This channel is apparently in English.

[@jacekc6179]

@@MedicalDeviceHQ Maybe i was just tired . Will listen again.