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.
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.