Software validation is key. This is mentioned on different standards, and this is required by the auditors to prove that your software is safe. This is valid for Software as a Medical Device SaMD but also to software used as a quality tool. ISO 13485 is asking you to validate software’s that are used to track quality data. 

In this episode, Christophe Girardey and Viriginie Rochat from Wega will explain to us the next level of the software validation which is the automation. Imagine that you can automate your validation and you don’t need to test everything manually. That would save you a lot of time. But what are the benefits or pitfalls of it?  

Don’t miss this episode if you are in software development or if you use Software to manage quality data. 

Who is Christophe Girardey? 

Christophe Girardey is Managing Director at Wega, a life science consulting company specializing 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. 

Who is Virginie Rochat? 

Virginie is leading the Test Automation team at wega, a life science consulting company specialized in digitalization. The Test Automation team is composed of people with a broad range of backgrounds -  from software and testing engineers to QA and Validation specialists - in order to support Pharmaceutical and Medical Device companies when it comes to automate end-to-end testing. With its expertise in user interface test automation tools, wega can support you through the selection of the proper tool based on your needs and infrastructure, validate the tool and then help your teams into the development of automated test cases and provide the necessary experience to support your team to reach compliance in a more efficient way. 

Virginie has more than 10 years of experience within pharma laboratories. She has always been keen to automate repetitive tasks and prone to adopt new technologies to improve the efficiency of the business processes, leading her to develop more and more knowledge on informatic and technologies, to bridge the gap between Science and IT. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

Article on Test Automation: https://www.wega-it.com/en/automatisierung-von-softwaretests-fuer-nutzeranforderungenChristophe

Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/

Virginie Rochat Linkedin: https://www.linkedin.com/in/virginie-rochat86/

wega Website : https://www.wega-it.com/ 

Medical Device: https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice