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IZiel Healthcare Technical File, QMS Documentation & Regulatory (USFDA, CE) Approvals for Medical Device Companies.

22/07/2025

🔍 Can your device pass the grandma test?
If a user can’t figure it out without a manual, that’s not a user error — that’s a design flaw.

In MedTech, 80% of device errors are user-related — and most are preventable.
That’s why Human Factors Engineering (HFE) isn’t just a checkbox — it’s your frontline for safety, compliance, and market success.

At IZiel, we embed HFE and human-centered design into the device development process from Day 1 — not as an afterthought.

We align with global standards:
âś… IEC 62366 for usability
âś… ISO 20417 for clear, compliant Instructions for Use (IFUs)

Because usability = safety + compliance.
Let’s simplify your interface — and satisfy regulators too.

🟢 Book a usability audit today: www.iziel.com

đź”§ End-to-End Excellence in Firmware, Software & ComplianceIZiel Healthcare successfully completed a project for a diagno...
19/04/2025

đź”§ End-to-End Excellence in Firmware, Software & Compliance

IZiel Healthcare successfully completed a project for a diagnostic equipment manufacturer, enhancing their software validation process and achieving remarkable efficiency and compliance.

Through smart automation and rigorous protocols, we:
âś… Reduced manual testing efforts by 40%
âś… Enhanced testing accuracy and reliability
âś… Achieved full FDA & CE compliance

At IZiel, we power diagnostic innovation with speed, safety, and precision.

🎯 Want to learn how?
Join our upcoming webinar:
“Critical Considerations in Firmware & Software Development for SiMD and SaMDs”
Explore key strategies, tools, and lessons from real-world implementations.

đź“… Register now: https://iziel.com/events-webinars
www.iziel.com | sales@iziel.com

📢 Webinar Alert: Design for Manufacturability (DFM) for Medical Devices!Want to optimize your medical device design for ...
28/02/2025

📢 Webinar Alert: Design for Manufacturability (DFM) for Medical Devices!

Want to optimize your medical device design for cost-effective, scalable, and regulatory-compliant manufacturing?

Join Atul Mahajan, Director, Engineering Services, IZiel, as he shares key insights on DFM strategies to streamline manufacturing, reduce costs, and ensure compliance.

đź“… March 12th, 2025 - 11:00 AM CET
đź“… March 13th, 2025 - 12:00 PM EST

Key Topics:
🔹 Importance of DFM in Medical Device Development
🔹 Strategies to Reduce Manufacturing Costs Without Compromising Quality
🔹 Material Selection for Biocompatibility and Regulatory Compliance
🔹 Optimizing Tolerances and Design for Assembly (DFA)
🔹 Aligning Designs with FDA, EU MDR, and ISO 13485 Requirements
🔹 Common Pitfalls and How to Avoid Costly Redesigns

🚀 IZiel Healthcare specializes in Medical Device Design, Development, and Regulatory Compliance, helping MedTech companies bring safe and innovative products to market.

đź”— Register now: https://iziel.com/events-webinars/

IZiel is Attending HIMSS 25 from March 3-6, 2025, in Las Vegas!HIMSS is a leading event that gathers healthcare professi...
26/02/2025

IZiel is Attending HIMSS 25 from March 3-6, 2025, in Las Vegas!

HIMSS is a leading event that gathers healthcare professionals to dive into the latest breakthroughs in Digital Health, Medical Devices, and Health IT. We're excited to engage in thought-provoking conversations and build valuable connections with industry leaders.

📍 Venue: The Venetian Convention & Expo Center, Caesars Forum, and Wynn Las Vegas
đź“… Dates: March 3-6, 2025

See you there!

đź“© Reach out to schedule a meeting:
Atul Mahajan: https://calendly.com/atul-mahajan-izielhealthcare

The regulatory landscape for PFAS in medical devices is evolving rapidly, presenting complex compliance challenges for o...
15/10/2024

The regulatory landscape for PFAS in medical devices is evolving rapidly, presenting complex compliance challenges for organizations. Staying ahead of these changes is crucial for maintaining regulatory standards and ensuring product safety.

Join our upcoming webinar on "Effective Change Management - The Evolving PFAS Story"

Whether you're working in medical device design, development, or compliance, this session will equip you with valuable strategies to adapt to the evolving regulatory environment.

⏩ Follow the link to secure your spot!
https://iziel.com/events-webinars/

See you tomorrow at The MedTech Conference 2024!Let’s connect and discuss the Medical Device Design, Development and Reg...
14/10/2024

See you tomorrow at The MedTech Conference 2024!
Let’s connect and discuss the Medical Device Design, Development and Regulatory Compliance needs in the MedTech industry.

⏩ Visit us at Booth 615
https://iziel.com/medtechconference/

🌸 Onam at Iziel Bangalore! 🌸Our Iziel Bangalore team came together to celebrate the joy and spirit of Onam! From colorfu...
16/09/2024

🌸 Onam at Iziel Bangalore! 🌸

Our Iziel Bangalore team came together to celebrate the joy and spirit of Onam! From colorful pookalams to delicious feasts, it was a day full of tradition, unity, and happiness.

Grateful for the wonderful memories and looking forward to more celebrations together! ✨

Celebrating Success and Unity! IZiel's annual employee meeting for 2024-25 was a phenomenal event. Hard work was celebra...
16/05/2024

Celebrating Success and Unity! IZiel's annual employee meeting for 2024-25 was a phenomenal event. Hard work was celebrated, team members were honored for their outstanding contributions, and our talented group showcased their skills in a mix of dance, singing, and mime that left everyone in awe!
Here's to dazzling moments and unstoppable energy at the , which brought together teams from Bangalore, Pune, and beyond!

Join us for an insightful webinar on Software Development, Validation, and Embedded Systems for Medical Devices and expl...
04/02/2024

Join us for an insightful webinar on Software Development, Validation, and Embedded Systems for Medical Devices and explore the latest advancements in the healthcare technology space.

EUROPE/ASIA - 7th February, 2024 11.00 AM CET

USA/Latin America - 8th February, 2024 12.00 PM EST

To Register Please visit https://lnkd.in/d8KY8kUt

We look forward to connecting with industry leaders and explore business collaborations with leading Medical Device manu...
27/01/2024

We look forward to connecting with industry leaders and explore business collaborations with leading Medical Device manufacturers.

26/12/2023

12/11/2023

Address

IZiel Healthcare Pentagon P1, Office No. 601 & 604, Magarpatta City, Hadapsar, Pune

411028

Opening Hours

Monday 09:00 - 17:00
Tuesday 09:00 - 17:00
Wednesday 09:00 - 17:00
Thursday 09:00 - 17:00
Friday 09:00 - 17:00

Telephone

+917276212555

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