The shortest path to medical device approval
Medical device manufacturers are facing increasing scrutiny from regulatory bodies, as their devices are becoming increasingly complex and interconnected. Designing and manufacturing such devices using manual methods and homegrown technologies has not made economic sense for quite some time as the pressure to produce more capable, safer, and higher quality devices faster continues to ramp up the competition among device manufacturers. Furthermore, it is the responsibility of the device manufacturer to prove that these devices are safe and effective for their intended use. One step in the process to prove their safety and effectiveness is to develop and document processes using rigorous standards such as IEC 62304.
In this webinar, QNX and LDRA will identify some industry best practices for using 3rd party software components in medical devices and offer details on:
- IEC 62304 objectives and requirements
- The value of static analysis in medical device development
- Dynamic coverage analysis and the positive impact on the device approval process
- Unit/integration automated testing – saving time and money in medical device development
- Adoption of multi-core processors enabling reliability, performance, safety, and security in medical devices
- How to leverage Clear SOUP in medical devices
- How a complete set of documentation from your software provider can shorten test and validation cycles
Chris Ault, Product Marketing Manager, QNX Software Systems
Chris is a technical product manager responsible for QNX Software Systems’ product portfolio. Before joining QNX, Chris was a senior product manager focused on virtualization technologies. Prior to this assignment, he held positions of increasing responsibility with hardware and software vendors, including Ciena, Nortel, Catena Networks and Liquid Computing.
Shan Bhattacharya, Business Development Manager, LDRA
Shan Bhattacharya is a Business Development Manager for LDRA. He also manages the US Field Engineering team. In his tenure with LDRA, Shan has worked with medical device manufacturers to improve their software development and verification workflow to comply with standards such as IEC 62304. Shan also has significant industry experience in aerospace, defense, industrial, and automotive verification and compliance activities.
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