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.
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 this interview Dr. Edmond W Israelski, Director, Human Factors, Abbott Quality and Regulatory, Abbott shares his top tip for successfully applying human factors in design controls during the design of a medical devices and how to avoid common pitfalls in design.
Earlier this month Pharma IQ opened up the opportunity for pharma and biotech professionals to submit their burning compliance questions on software for medical devices.
Now, the MHRA’s Senior Regulatory Specialist for Devices – Rob Higgins - takes the floor on the subject.
In this exclusive interview Patrick Reichmann, Quality Assurance & Regulatory Affairs Manager at Agfa HealthCare, speaks about the main challenges being faced by companies in regulatory affairs and what he thinks will be the major trends in the regulatory side of medical device software in the next couple of years. Reichmann also runs through the key steps in applying the ISO 27k framework in order to advance information security and privacy and discusses the importance of safeguarding your existing legacy products.
If a patient is rushed into theatre with a heart attack, firstly a catheter will be placed in the arteries of the patient’s heart. Then physicians or the cardiologists can usually start with the therapy and concentrate on stenting and other interventions.
Meanwhile, in the background through a complex algorithm the PiCSO Impulse System will work to increase the venous pressure through a balloon catheter placed in the heart’s coronary sinus to re-perfuse the myocardium without damaging the coronary sinus or other tissue and prevent ischemic damage.