Medical Device News with Podcast and LinkedIn Audio

Podcast

What was the topic of this week's podcast??? Let's discover:

Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between the Software Development team and the Quality and Regulatory Affairs team. Dev team think that they have too much documents to create and quality thinks that the document that the dev team is creating is not really answering the requirements. So how to solve that.?

Christophe Girardey from Wega who is dealing with that will tell us why we have this situation and also provide some hints on how this can be resolved.?

Who is Christophe Girardey??

Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.?

Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.?

Full episode: https://podcast.easymedicaldevice.com/237-2/

Linkedin Audio

This Friday June 23rd 4pm CET we are experiencing a new way to deliver content with a LinkedIn Audio.

I have tested it and this reminds me the ClubHouse application which is also great but was difficult of access for some of the community members.

So this session will be fully on LinkedIn and free to attend to anyone. Just accept the invitation and you'll be notified when the session starts.

What is fun is that you can also participate and not just listen. So you will be able to ask your questions to me or my guests.

This week my guest will be Karandeep Singh Badwal and we will try to discuss the latest changes to the regulation.

Don't hesitate to listen while working or during your commute. And share that also with your colleagues. If you have some ideas on items to cover during next sessions, let me know.

Link to the event: https://www.dhirubhai.net/events/let-stalkmedicaldeviceregulatio7077537912430419968/

Green Belt training (Postponed)

We have announced a session for the Green Belt training this June 26th, but after receiving many messages that people cannot enroll, we identified an issue on the webpage. So to fix that I will need some time.

This is why I decided to postpone this session. The new date will be communicated but most likely this will happen in August or September.

Sorry for the inconvenience.

Easy Medical Device support

Easy Medical Device is a consulting firm that can help you for:

• Consulting
• Authorized representative for EU, UK and Switzerland
• Importer for EU and Switzerland
• Training
• eQMS

So if you need to contact us, go to easymedicaldevice.com