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.
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.
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. In this guide, you will find questions and suggestions developed to help teams generate their own software SOPs.
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
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 check whether it is really what our customer actually needs and will use. This kind of balance is not merely allowed by FDA, but is in fact more compliant than what most companies do now.
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 of developing a medical device.
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.
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.
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.
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.
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 United States.
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!
“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 belt. They want something that looks cool, like an iPod, its got colour to it or sparkles,” said Sean Fenske, Editor-in-Chief for Medical Design Technology (MDT).
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.
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...
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.