Regulatory Changes and Development
Klaus Moritzen, Process Manager for Verification and Validation at Siemens Healthcare, discusses the contribution of Verification and Validation to medical device software development. He also touches the dichotomy between regulatory compliance and value creation.
In the medical device industry, the issue of software design is an important one. It can not only improve homogeneity and streamline processes, allowing for increases in safety and production, but also has to comply with a strict range of ever-changing and evolving regulations.
Interview transcript - Rainer Voelksen, Vice-President for International Regulatory Affairs at Edwards Lifesciences, joins Pharma IQ to discuss why standards should have internationally compatible software requirements. He also touches upon the European QM approach, the GHTF project and the International Medical Device Regulator Forum in the interview.
Controversy & Confusion: What Does Annex Z of EN/ISO 14971: 2012 Mean & How Can We Practically Implement It?
Chuck Sidebottom, Director, Corporate Standards at Medtronic and Dave Osborn, Manager, International Standards at Philips, discusses the current controversy over the application of risk management under the European medical device directives, how the expectations for risk management have changed, how EN/ISO 14971 has been revised to deal with these expectations and how manufacturers and notified bodies are reacting to these revisions, which are causing a degree of confusion.
In the medical device industry, the issue of software design is an important one, but one which is often affected by the need to comply with industry regulations. Across Europe, complying with the EU Medical Device Directive has been a tough challenge for many companies, but in the US, organisations have had to struggle with a lack of legislative action due to a change of congress and uncertainty about what the new congress has planned
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!