Facilitate compliance with medical device regulatory standards
Medical devices: Regulatory standards and compliance
Using multicore and virtualization for secure, robust medical devices (OSM)
Join us as our presenters will show how applying the latest in standards-compliant development, test and virtualization technologies can enable safer, more secure, and more reliable medical devices.
Quality assurance for medical devices
View this webcast to learn how the RSSES provides a tool infrastructure that integrates planning, project governance, and process enactment along with the traditional engineering activities of systems and software development
Developing medical devices with safety, reliability and security in mind
This talk will dive into these three key pillars of design, particularly on the software side, and provide insight into the interdependencies that make these critical medical devices run.
Achieving medical device software compliance under IEC 62304
This webinar will discuss the software development activities that you need to include in your process and the deliverables you need to create to ensure that you meet the IEC 62304 standard with a minimum of headaches and a high level of employee compliance.
Optimizing your healthcare product portfolio strategy: Balancing marketplace needs with strategic goals and profitability
View this webcast to learn how medical device, pharmaceutical and biotechnology companies are faced with many of the same goals and challenges as traditional product-focused companies—reducing production costs, improving time to market, growing product revenue—but with more rigid concerns about the complexities of adhering to compliance and regulatory mandates.
Building a medical device tricorder!
This podcast discusses the regulatory compliance considerations and the key product development lifecycle practices that are needed to build Smartphone-based medical devices.
Being agile while still being compliant: Diagnostic Grifols
Although Medical Device regulations do not enforce a fixed life cycle model, activities are presented in a sequential manner hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from Agile development methods. A number of Medical Device manufacturers have adopted Agile practices while keeping development in compliance, but conflicts arise and decisions have to be taken in favor of agility or formality.
Being agile while still being compliant
Experts from IBM and Diagnostic Grifols describe how Diagnostic Grifols is using agile software development approaches in the tightly regulated field of medical devices. "Many organizations believe that they must use a waterfall approach in regulated environments," they say. "We show how this is not the case."
Agile analysis practices for safety-critical software development
Because of their discipline and efficiency, agile development practices should be applied to the development of safety-critical software. Bruce Douglass, author of the IBM Rational Harmony for Embedded RealTime Development process, explains the key analysis practices for the development of safety-critical systems and how they can be realized in an agile way.
Three steps to rapid development of high-quality medical devices within regulatory norms
Medical device developers face challenges that are different from developing products in most other industries. Chief among these is the imperative of compliance with safety regulations and industry standards. Three IBM experts describe three steps that help accelerate development, yet still produce high-quality devices that comply with regulations.
Ideas in action: Diagnostic Grifols
Learn how Diagnostic Grifols used agile approaches in accordance with TIR 45 and passed FDA audit, thus proving that agile is no barrier to regulatory compliance.
Case study: Diagnostic Grifols
Diagnostic Grifols, a leading medical device provider, implementing an Agile solution to enhance collaboration throughout its product development cycle, sees significant results in time to market and regulation compliance.
Better decision support for medical devices product management
In this podcast we will discuss how IBM Rational Focal Point software provides a full audit trail to help medical device companies ensure regulatory compliance and capture enhancement requests, product ideas, market needs and technical needs for product development.
Meeting your FDA design control needs with requirements and change management
For most medical device companies, the design control requirements of the FDA, as defined in 21 CFR Part 820, are fundamental to the business of developing products. The challenge is how to ensure that you remain compliant to these regulatory needs while reducing the overhead in doing so.
A medical device manufacturer spreads information to save lives
Major medical device manufacturer gains a competitive advantage and provides revolutionary improvements to cardiac patient care through a remote Patient Care Network. IBM Global Business Services is their innovation partner engaged in the design, development, and implementation.
Saving you pain while you save lives
Learn how IBM Rational solutions can help you meet regulatory compliance with enhanced automation and reporting, integrated requirements and quality management and early defect detection and removal.
IBM Rational solution for medical devices
Learn about the IBM Rational medical device solution, covering the collaboration, guidance in conforming to FDA Quality System Regulation, change management and requirements management.
Three steps to rapid development of high-quality medical devices
Medical device developers face challenges that are different from developing products in most other industries. Three IBM experts describe three steps that help accelerate development, yet still produce high-quality devices that comply with regulations.
Security in eHealth: Designing software to connect devices safely
Learn about the issues in interoperability between embedded devices and the eHealth cloud, and what is critical to understand about embedded medical software design to ensure security is built in from the start without sacrificing capability.
Critical steps to ensuring standards compliance
Applying the latest in standards-compliant development, test and virtualization technologies can enable safer, more secure, and more reliable medical devices.
Challenges and opportunities for the medical device industry
What does IEC 62304 compliance means for manufacturers and what systems and software engineering best practices are used in many of today’s most successful companies.