While establishing design controls and proper documentation can be daunting, this process can have many positive downstream effects. In this podcast Michael Meissner, VP Software R&D and Program Manager, Omnyx LLC (a GE and UPMC joint venture) talks about using Agile methods to ensure successful audits.
With over 30 years in the industry, Chuck Sidebottom Director of Corporate Standards at Medtronic is excellently placed to analyse trends in the medical device industry. When he spoke with Pharma IQ, Chuck discussed recent shifts in regulatory emphasis and predicted how this emphasis will change in the future. He also discussed the importance of and difficulties involved in instilling a culture of compliance across multiple offices and in multiple jurisdictions.
With increasing software sophistication and complexity, are security vulnerabilities an inevitability? We spoke with Arnab Ray, Senior Research Scientist at the Franuhofer Center about the issues surrounding device security and how the will effect companies in the coming years.
Danielle Giroud, Founder of the World Medical Device Organisation, discuss regulatory changes in the medical devices market in both the EU and US, as well as her perspective on the recent updates to the Medical Devices Directive.
Many companies struggle to understand regulatory expectations of their submissions which can lead to long and costly delays. We spoke to Arnab Ray, Senior Research Scientist at the Franuhofer Center who gave us his key points to ensuring a smooth regulatory submission process
Werner Kexel discusses the 3rd revision to the standards guideline 60601 and tips for medical device manufacturers on how to prepare for the changes!
“There is more attention being paid to the consumer, designs are not cold and clinical, very hospital looking. There is definitely a trend to make these almost like consumer devices. If a child needs a diabetic pump they don’t want this very cold looking device on the clip to their belt. They want something that looks cool, like an iPod, its got colour to it or sparkles,” said Sean Fenske, Editor-in-Chief for Medical Design Technology (MDT).
Srdjan Capkun from Swiss Federation Institute of Technology on Securing Access & Reprogramming of Medical Devices
Srdjan Capkun discusses Securing Access and Reprogramming of Medical Devices including the key challenges and risks associated with wireless implants and how we can solve them.
“Although tremendous inroads have been made, the implanted medical device is just at the beginning of its broad impact on medicine and health," said Glen Griffith, Principal RF Communication Engineer, Alfred Mann Foundation. Find out more...