WEBINAR ON-DEMAND
Medical Device Certification, are we on the right path?

With the ever-growing demand for critical medical devices, and the phase at which these devices need to be designed, developed, certified, launched, and maintained in the current situation, following the right path towards certification is critical.

Medical device certification requires an amalgamation of multiple standards, country-specific regulations(FDA/EU MDR), and liability considerations. While major manufacturers suppliers have mastered the certification path with years of best practices, lessons learned, and by burning their hands during exploration, the startups/newer entrants find the certification processes daunting and exhausting.

This webinar would try to provide fundamental insight into the risk-based approach (ISO 14971), quality management system (ISO 13485), software consideration (IEC 62304), and device-specific requirements (IEC 60601). In this webinar, security aspects (FDA and AAMI guidelines) of medical devices will be discussed briefly to bring out a holistic view of product development in the software lifecycle context.

Adherence to standards comes with its challenges, and this webinar would talk about the common challenges faced throughout the software development life cycle. And how LDRA’s highly customizable and tailor-made solutions could assist product developers in standard and certification compliance.

Key Takeaway
• Learn about safety life cycle and activities
• Learn about the importance of QMS and the Risked-Based approach
• Learn about the important objectives to be achieved for safety/security software development life cycle
• LDRA’s Start-up Eco-system (Tools, Consulting, Mentoring and Connect)

Who Should Attend?
• Software engineers and engineering managers who wants to learn about developing software in compliance with medical device standards.
• Systems engineers who are interested in learning about the interface between systems and software in a safety-critical environment.
• Quality engineers, safety engineers, and risk assessors who aspires to raise in their roles, responsibilities, and activities in medical product development.

Speaker Info:

Anil Kumar N.G is a Technical Manager with LDRA Technology Pvt Ltd, India and comes with over 15 years of experience in the development and verification of real-time embedded systems. He is a Level 1 “Functional Safety Certified Professional” in accordance with IEC 61508/IEC 61511.

His Core experience includes the development of startup codes, low-level drivers and BSP for various target platforms and RTOS. He has guided customers at different phases of the software development lifecycle and helped them to achieve compliance to various safety-critical industry-specific standards and guidelines. He has also helped several customers for achieving Object Code Verification on various target platform involving complex development environment.

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