Harsh Jain

Product Quality Engineering Manager Align Technology

Harsh Jain has over 12 years of experience in product quality engineering within the Medical Device industry (Lab analysers, Arthroscopic, Software as Medical Device, Tissue ablation, Blood Management, Sequencing, Digital Health). He has comprehensive knowledge of the Medical Device development life cycle, risk assessment, US and International regulations including 21 CFR 820, ISO 13485, ISO 14971, IEC 62304 and IEC 62366.

Harsh develops quality strategy roadmaps of novel and unique medical devices for design control, change management, Verification and Validation, and risk management including cybersecurity. Having completed an undergraduate degree in Mechanical Engineering, Harsh completed two Masters; one in Regulatory Affairs in Medical Devices and another in Computer Science. He has also achieved the ASQ Software Quality Engineer certification.

Conference Day One

9:10 AM OPENING PANEL DISCUSSION: EVALUATING THE RAPID GROWTH AND DEVELOPMENT OF THE MEDICAL DEVICES INDUSTRY

Bringing together a panel of knowledgeable voices, with an overview of the digital health and medical technology sector, this opening session will consider how the COVID-19 pandemic has accelerated interest in the opportunities that digital health technologies and Medical Device Software offers and how this is being reflected in the industry:

  • How has the COVID-19 pandemic accelerated the development and adoption of Medical Device Software to diagnose, treat and manage patients?
  • Understanding the developing start-up landscape and the emergence of new health technologies
  • What is the impact on existing Medical Device manufacturers?
  • How should the industry respond to meet the demand and maximise the opportunity of this moment in time?
  • What are some of the potential challenges and how might these be overcome?

 

2:55 PM APPLYING A RISK MANAGEMENT STRATEGY TO CYBERSECURITY THROUGHOUT THE PRODUCT DEVELOPMENT LIFECYCLE

Verily Life Sciences is at the convergence of healthcare, data science and technology, with its key focus on building integrated solutions to improve human health.

  • Understanding the importance of end-to-end risk management when considering cybersecurity
  • Outlining the critical success factors for the integration of risk mitigation techniques
  • Sharing examples of how existing cybersecurity mitigations have been integrated into the product lifecycle development and where there is room for further development 

Check out the incredible speaker line-up to see who will be joining Harsh.

Download The Latest Agenda