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.
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.
Many in the area of software design for medical devices area have already moved to Agile and last year’s survey suggests that many more are thinking of implementing Agile methodology. However, the first step is the hardest and when starting out the choice can feel so vast as to be paralyzing. To counter this, Nancy Van Schooenderwoert, President and Managing Director of Agile Development Practice has written a hypothetical case study to simplify the process. In this article, she also gives her 6 don’t and 5 do’s for those who want to implement Agile.
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.
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.
Medical devices are undergoing a technical transformation in terms of software, interconnectivity and interoperability. This increase of function comes with an increase in risk from cybersecurity threats which puts not only the patients with medical devices potentially at risk, but has wider implications for connected digital infrastructure too.
The safety, security and privacy of patients must be protected and the providers of software for medical devices must work with regulators and the wider industry to ensure this.
“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...
Medical Device companies operating in today’s stringently regulated environment require comprehensive software systems and solutions that deliver robust functionality and support full compliance with regulatory requirements. In the area of software design for medical devices, adherence to the applicable regulations and standards is a complex and expensive process.
Ahead of the 8th annual SDMD conference Pharma IQ surveyed 100+ relevant individuals about the challenges, investments and predicted future trends in this area.
Medical devices, like other computer systems, are vulnerable to security breaches that potentially impact the safety and effectiveness of the device. Recent security scandals have shown that hackers are increasingly developing new and effective methods of executing cyber attacks on the historically lax security embedded within medical devices. As a result, device security has taken on a new urgency for manufacturers and healthcare providers.
This piece discusses the changing nature of cybersecurity threats in the medical device space, and the role of political, regulatory and organisational influences on the prevention of cyber breaches.