IZiel Healthcare

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

22/07/2025

๐Ÿ” Can your device pass the grandma test?
If a user canโ€™t figure it out without a manual, thatโ€™s not a user error โ€” thatโ€™s a design flaw.

In MedTech, 80% of device errors are user-related โ€” and most are preventable.
Thatโ€™s why Human Factors Engineering (HFE) isnโ€™t just a checkbox โ€” itโ€™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 โ€” not as an afterthought.

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

Because usability = safety + compliance.
Letโ€™s simplify your interface โ€” and satisfy regulators too.

๐ŸŸข Book a usability audit today: www.iziel.com

๐Ÿ”ง End-to-End Excellence in Firmware, Software & ComplianceIZiel Healthcare successfully completed a project for a diagno...
19/04/2025

๐Ÿ”ง 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:
โœ… Reduced manual testing efforts by 40%
โœ… Enhanced testing accuracy and reliability
โœ… Achieved full FDA & CE compliance

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

๐ŸŽฏ Want to learn how?
Join our upcoming webinar:
โ€œCritical Considerations in Firmware & Software Development for SiMD and SaMDsโ€
Explore key strategies, tools, and lessons from real-world implementations.

๐Ÿ“… Register now: https://iziel.com/events-webinars
www.iziel.com | sales@iziel.com

๐Ÿ“ข Webinar Alert: Design for Manufacturability (DFM) for Medical Devices!Want to optimize your medical device design for ...
28/02/2025

๐Ÿ“ข 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.

๐Ÿ“… March 12th, 2025 - 11:00 AM CET
๐Ÿ“… March 13th, 2025 - 12:00 PM EST

Key Topics:
๐Ÿ”น Importance of DFM in Medical Device Development
๐Ÿ”น Strategies to Reduce Manufacturing Costs Without Compromising Quality
๐Ÿ”น Material Selection for Biocompatibility and Regulatory Compliance
๐Ÿ”น Optimizing Tolerances and Design for Assembly (DFA)
๐Ÿ”น Aligning Designs with FDA, EU MDR, and ISO 13485 Requirements
๐Ÿ”น Common Pitfalls and How to Avoid Costly Redesigns

๐Ÿš€ IZiel Healthcare specializes in Medical Device Design, Development, and Regulatory Compliance, helping MedTech companies bring safe and innovative products to market.

๐Ÿ”— 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.

๐Ÿ“ Venue: The Venetian Convention & Expo Center, Caesars Forum, and Wynn Las Vegas
๐Ÿ“… Dates: March 3-6, 2025

See you there!

๐Ÿ“ฉ Reach out to schedule a meeting:
Atul Mahajan: https://calendly.com/atul-mahajan-izielhealthcare

Address

IZiel Healthcare Pentagon P1, Office No. 601 & 604, Magarpatta City, Pune
Hadapsar
411028

Opening Hours

Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

Telephone

+917276212555

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