JOIN OUR WEBINAR

Date & Time: 13th March 2025, 3:00 – 4:00 PM IST

Overview

iOrbit Digital Technologies, in collaboration with QTICS Group and Globizz, invites Indian medical device manufacturers to an exclusive webinar on navigating regulatory pathways for global market expansion.

With evolving regulatory landscapes, obtaining EU MDR and FDA approvals is essential for Indian manufacturers aiming to establish a strong presence in international markets. This session will offer actionable insights, expert guidance, and real-world strategies to streamline compliance, reduce time-to-market, and unlock new growth opportunities.

Who Should Attend?

• CEOs, R&D Heads, Product Heads, and Regulatory Heads of Indian Medical Device Manufacturing Companies

Why Attend?

Gain first-hand insights from industry experts on how to navigate complex regulatory challenges, ensure product compliance, and position your business for success in Europe and the US.

Agenda

• iOrbit Digital Technologies: Redefining MedTech in Digital Health - Bipin RR, CEO – iOrbit
• QTICS Group: How to Effectively Navigate the Labyrinth of EU MDR Conformity? - Andras F. Toth, Head of Medical Division, QTICS Group
• Globizz: Key Considerations for FDA Approval and Medical Device Business in the US - Miyuki Nagao, Senior Manager, Globizz Corp
• Q&A Session (15 minutes)

Presentation Details

iOrbit Presentation

Title: Redefining MedTech in Digital Health

Presenter: Bipin RR, CEO – iOrbit

The digital revolution is transforming healthcare in ways we once thought impossible. Traditional hospital-based medical devices are increasingly being adapted for home use, and real-time data collected from these devices is becoming crucial for diagnostics and clinical decision-making.

QTICS Presentation

Title: How to Effectively Navigate the Labyrinth of EU MDR Conformity?

Presenter: Andras F. Toth, Head of Medical Division, QTICS Group

• Insights for the European medical devices market
• European legal requirements for medical device manufacturers
• Preclinical tests including safety, biocompatibility, and cybersecurity assessments

Globizz Presentation

Title: Key Considerations for FDA Approval and Medical Device Business in the US

Presenter: Miyuki Nagao, Senior Manager, Globizz Corp

• Overview of the U.S. Medical Device Market
• Challenges in obtaining FDA 510(k) clearance
• Critical steps for successfully obtaining FDA approval
• The importance of entering the U.S. Market
  • Potential and influence of the US market
• Successful US market entrance
  • FDA overview and approval flow
  • Importance of building a strategy for successful FDA approval
  • US business customs

About Bipin RR

Founder & CEO, iOrbit Digital Technologies

Bipin RR is the Founder CEO of iOrbit Digital Technologies, a medical devices company with a global presence in Europe, USA, and India. iOrbit operates at the convergence of Clinical, Behavioral, and Technology, serving a broad clientele worldwide.

iOrbit's Capabilities

• ISO 13485 certified organization with world-class SOPs for medical device development.
• Developed the world’s only IoT platform exclusively for medical devices, meeting EUMDR, MDSAP, GDPR, CE, and FDA standards.
• Offers a licensable AI engine capable of processing test results, reports, and images to extract patterns from datasets.

Business & Market Strategies

• Co-investment opportunities in product development.
• Integration of off-the-shelf MedTech technology components to reduce time-to-market.
• White-labeling IoMT products for cloud-connected medical devices.
• Partnerships with hospitals and clinics for clinical testing.
• Licensing of FDA-certified products developed by iOrbit.

Professional Background

Before founding iOrbit, Bipin RR served as Vice President & Business Unit Head for IoT and Digital Business at Tata Elxsi, a Tata Group Company.

Education

• B.Tech in Electronics & Communication
• MS in Microelectronics from BITS, Pilani
• Executive MBA from IIM, Bangalore

About Miyuki Nagao

Global Manager, Globizz

Miyuki Nagao serves as the Global Manager at Globizz, where she plays a crucial role in supporting clients' entry into the U.S. market. She specializes in strategic project coordination, offering detailed project plans tailored to each client's unique needs and regulatory challenges.

Key Responsibilities

• Develops concrete project plans for medical device companies entering the U.S. market.
• Provides customized consulting services to align with each client’s unique business and compliance needs.
• Offers practical guidance for international expansion and regulatory approvals.

Industry Contributions

• Experienced speaker at international medical device seminars.
• Provides consulting services to help businesses navigate regulatory complexities.
• Expert in guiding companies through the FDA approval process for successful market entry.

Impact & Global Success

As a trusted advisor for medical technology companies, Miyuki has played a pivotal role in enabling businesses to expand successfully into international markets. Her insights and strategic support help companies overcome market entry challenges and achieve global success.

About András F. Tóth

Head of the QTICS Medical Division

András F. Tóth joined the QTICS Group in September 2021 as the Head of the Medical Division. He is responsible for supporting and developing the six-member division, organizing internal and external events, and promoting the division’s services both domestically and internationally.

Key Responsibilities

• Ensuring professional excellence, customer satisfaction, and business success.
• Promoting QTICS Medical’s services for international market expansion.
• Supporting medical device manufacturers through regulatory pathways.
• Helping QTICS Medical evolve into a global success story.

Professional Background

Before joining QTICS, András spent 25 years advancing volunteering in Hungary:

• Served as Program Director at the NIOK Foundation for 6 years.
• Worked as Director of the Volunteer Center Foundation for 19 years.
• Maintains a strong commitment to social responsibility and medical technology.

Leadership & Global Engagement

• Dedicated member of the BMW Foundation Herbert Quandt Responsible Leaders Network since 2014.
• Holds degrees in education and social policy.
• Brings nearly three decades of leadership and organizational experience.