Episode 11 – Medical Device Software Validation
Bill Stamm and Rafael Blanco from General Digital Software Services are helping us to have a better understanding of Software Validation. This topic is critical for Medical Device Manufacturers as the Healthcare world start to get digital.
More digital products that contain a software, more software on the manufacturing side, more software to verify software. I mean, software are everywhere.
The new EU MDR is strengthening the requirements for Software and we need then experts to help. Bill and Rafael are specialized on this and they are the right SMEs to tell us exactly which mistake to avoid.
I will also ask them about artificial intelligence as this is a kind of software that is more complicated.
They also asked me to share with you some documents like the V-shape which describe the software validation process. Don’t hesitate to download it on the resource section.
All the details to contact Bill and Rafael are below so don’t hesitate.
About Bill Stamm
Mr. Stamm is the Vice President of Software Services at General Digital Corporation. He leads the Software Services team in sales and business management, growing global customer relations and partnerships, and oversees all software development, certification, IV&V testing and documentation. Mr. Stamm joined General Digital in 2015. With over 25 years of experience in the field, his varied background has brought him from service and engineering into sales and marketing. Mr. Stamm has also owned several businesses and has worked as an international sales and marketing manager at various other technology companies, such as EMC and Practical Automation. Mr. Stamm holds degrees in Computer Engineering, as well as Business Administration and Management.
About Rafael Blanco
Mr. Blanco has extensive experience with Software Verification and Validation of Avionics systems and components. He has performed verification (integration testing, module testing, reviews) on Bleed Air Systems, Mechanical Actuators, Fuel Pumps, Fuel Tanks & Systems, Automatic Flight Control Systems, Engine Controls, Starters, Pneumatic Systems Equipment, Cooling Systems, Fly-by-Wire Systems and Flight Management Systems. With over 25 years of experience in testing and project management, he has successfully brought his customers through FAA (Transport Canada, JAA) certifications for DO-178 projects both as a Verification Engineer and a Project Manager.
About General Digital Software Services
The General Digital Software Services business unit has over 45 years of extensive software development, certification and testing expertise—including Independent Validation & Verification (IV&V)—in the most stringent safety critical environments in the world: medical (FDA, IEC62304, PMAs and 510(k)), industrial controls (IEC 61508, IEC 61131), aerospace & avionics (DO178), and pharmaceutical and general packaging and robotic equipment. Our services can encompass the full software life cycle from development to verification, or simply help with overflow work.
General Digital Software Services: http://gdsoftwareservices.com
Bill Stamm Linkedin:
Rafael Blanco Linkedin:
Medtech prediction 2019: https://podcast.easymedicaldevice.com/5
FDA – General Principles of Software Validation: https://www.fda.gov/downloads/MedicalDevices/…/ucm085371.pdf