Download the 2018 Agenda
SDMD 2018 is Europe’s only international forum dedicated to medical device software design and compliance. Download the agenda now to view the full list of speakers at Software Design for Medical Devices 2018.
Software Innovation: Heart Attack Intelligence
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 ...
Software for Medical Devices Investment Insight 2015 Report
In this report, Pharma IQ presents the results for its 2015 investment insight research for Software Design for Medical Devices.
MHRA Sounds Wake-Up Call for Medical Software Manufacturers
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 sub ...
Where to Start with Agile in Software Design for Medical Devices?
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 ...
Advancing Information Security and Privacy: The Key Steps in Applying the ISO 27k Framework
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 ...
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.
The FDA are Taking Cybersecurity in Medical Devices Seriously and So Should You
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 impl ...
Protect and Shield: RF Wireless Technology in Medical Devices
“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...
Software for Medical Devices Cyber Security
Ahead of the 2017 Software for Medical Devices conference, Pharma IQ brings you this whitepaper looking at what you need to know in regards to software cyber security for medical devices.
Software Design for Medical Devices - Survey Report 2017
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 app ...
Addressing Cybersecurity Threats in Medical Devices
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 historical ...
Additional Content Download
ITK Engineering Develops IEC 62304: Compliant Controller for Dental Drill Motor with Model-Based Design
Sensorless brushless DC (BLDC) motors are well-suited for use in dental drills. They operate with less abrasion than brushed motors, and are more reliable, quieter, and easier to maintain and sterilize. Compared with BLDC motors with sensors, sensorless BLDC motors are less expensive and more compact.
Headstart in Human Factor Principles with HE75
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.
Should We Follow Apple’s Example When Designing Medical Devices?
“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...
Software Design for Medical Devices Investment Activity
In a recent report, Pharma IQ discovered a selection of investment behaviours regarding medical device software design. This year, we ask a selection of experts to provide their analysis on those findings and their projections on how the industry will behave in the years ahead.
Regulatory Changes and Development
Verification and Validation – what is their contribution to medical device software 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.
Pressures of Software for Medical Devices
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.
Harmonization of Software Requirements through Standards
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...
Anticipating the future of software design for medical devices
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...
Regulatory Impact on Medical Devices - An Interview with Chuck Sidebottom
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...
Complexity Conundrum: New Threats to Medical Device Security- An Interview with Arnab Ray
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.
What's Next for the Medical Devices Market? Regulatory Changes
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.
Ensuring Smooth Regulatory Submissions in Software for Medical Devices- An Interview with Arnab Ray
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
Tips for Medical Device Manufacturers to Prepare for the Revised 60601 - by Werner Kexel
Werner Kexel discusses the 3rd revision to the standards guideline 60601 and tips for medical device manufacturers on how to prepare for the changes!
Thoughts for Developing Software Quality Procedures
Every company, every software development team works somewhat differently. Each distinct product category involves its own set of development tasks. A “one size fits all” approach to software quality procedures therefore is not useful; software SOPs instead need to be tailored to the team and tasks while fulfilling regulatory expectations....
Agile 101: Beginning the Agile Journey for Software Design in Healthcare An Introduction to the Principles, Practices, and FDA Compliance
Balanced progress is the hallmark of genuine Agile practices when you remove all the misinformation and poorly executed attempts. Balance in the sense that there is no point writing software faster than we can test it, testing it faster than we can deploy it, or designing it before we can...
Agile Software Info Pack
Pharma IQ prepared this Agile Info Pack, the definitive resource for professionals in the agile area. The guide summarizes the key issues related to new agile development in healthcare, changes in clinical evaluations for medical devices and tips on the agile techniques for a project and address the regulatory challenges...
Agile Software Development in a Medical Device Context
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.
Software Development for Medical Devices - Overcoming the Challenges of Compliance, Quality and Cost, An MKS White Paper
This paper reviews some of the key challenges facing the medical device industry, and examines the role that an application lifecycle management (ALM) platform can play in meeting these challenges.
CASE STUDY: Inomed Streamlines IEC 62304 Medical Device Software Certification
Since there is no margin for error in the software driving these innovative devices, Inomed established extensive processes to ensure software integrity. Such full-lifecycle quality processes are essential for complying with IEC 62304, a "harmonized" medical device software safety standard that has been adopted by the European Union and the...