WEBINAR ON-DEMAND
Standards and Methodologies for Developing Dependable Medical Devices for Global Markets

Every med-tech start-up wants to become global. The journey towards becoming global from local has a lot of opportunities and challenges.
               
LDRA is pleased to co-host this joint webinar with AIC-AMTZ MEDIVALLEY INCUBATION COUNCIL, Visakhapatnam, which will discuss technology trends in medical electronics and software. Participants will learn about the Risk Management & Design Control Process for medical devices and a standards-driven approach for certification where we shall briefly explain IEC 62304, ISO 14971, ISO 13485, AAMI & FDA Security Guidelines.

The webinar will also share the ‘Top 5 Recommendations to Attain International Certification’.

Key Takeaways:

1. Technology Trends in Medical Electronics & Software
2. Risk Management and Design Control Process for Medical Devices
3. Standards Driven Approach for Certification
a. The need for standards
b. The difference between quality, safety & security.
4. Brief explanation of IEC 62304, ISO 14971, ISO 13485, AAMI and FDA Security Guidelines
5. Journey Towards Certification & Challenges
a. Recommendations to attain international certification
b. Reactive vs proactive approaches

Presenters:

Shinto Joseph - Director - South East Asia Operations, LDRA India.
Profile: https://www.linkedin.com/in/shinto-joseph-b69b56a/

Anil Kumar N G - Senior Technical Manager, LDRA India.
Profile: https://www.linkedin.com/in/anilkumarng/

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