Elexes Medical Consulting Pvt Ltd

Elexes Medical Consulting Pvt Ltd We are dedicated to the project at hand and have the expertise to quickly address all your regulatory needs. Let us take care of regulations so you can foc

"Every idea is a good idea! What it needs is a strong Regulatory and Quality support to see the light of the day". We are here for bringing new technologies to the market and helping you to ensure the safety and efficacy of the existing ones. Learn how Our Regulatory and Quality services can foster your needs in achieving your mission by saving in timelines and resources at best industry rates.

MHRA is consulting on proposed changes to the medical device regulations in the UK.The proposals include improved patien...
29/05/2026

MHRA is consulting on proposed changes to the medical device regulations in the UK.

The proposals include improved patient safety measures, updated oversight of software- and AI-enabled medical devices, and enhanced post-market surveillance expectations.

As medical technologies continue to evolve, these proposals could shape how devices are assessed, monitored, and managed in the future.

Stakeholders across the healthcare and medical device industry may want to review the proposed direction carefully.

Wishing you a joyful Easter filled with hope, renewal, and fresh beginnings. 🌸🐣May this season bring positivity, growth,...
05/04/2026

Wishing you a joyful Easter filled with hope, renewal, and fresh beginnings. 🌸🐣

May this season bring positivity, growth, and new opportunities for you and your team.

Happy Easter from all of us! ✨

Australia’s TGA reminds manufacturers to confirm whether their product requires ARTG inclusion before supplying a medica...
12/03/2026

Australia’s TGA reminds manufacturers to confirm whether their product requires ARTG inclusion before supplying a medical device in the Australian market.

To market a device in Australia, companies typically need to consider the intended medical purpose, risk classification, and possible regulatory exemptions.

This update serves as guidance, not a new regulation.

More details: https://www.elexes.com/tga-artg-medical-device-registration-australia/

As we step into 2026, we wish you a year filled with happiness, success, and new opportunities.Happy New Year! 🎉 ...
01/01/2026

As we step into 2026, we wish you a year filled with happiness, success, and new opportunities.
Happy New Year! 🎉

Wishing you all a Merry Christmas and a holiday season full of happiness and cheer. 🎄
25/12/2025

Wishing you all a Merry Christmas and a holiday season full of happiness and cheer. 🎄

Microsoft has ended support for Windows 10, which may negatively affect medical devices that still rely on it as their p...
11/12/2025

Microsoft has ended support for Windows 10, which may negatively affect medical devices that still rely on it as their primary operating system. Without ongoing security updates, these devices lose essential protection and become more vulnerable to cyberattacks.

Manufacturers and users are encouraged to review their devices’ operating systems, assess the risks, and consider either upgrading or enrolling in ESU to maintain safety and compliance.

Read more: 👉 https://www.elexes.com/news-windows-10-end-of-support-medical-devices-impact/

Big news for the medical device industry! The TGA has introduced onl...
04/12/2025

Big news for the medical device industry!

The TGA has introduced online tools to support non‑IVD devices transitioning to EU MDR.
a. Assessment tool to check eligibility
b. Notification form to keep TGA updated.

These steps ensure safer devices and an uninterrupted supply for patients.

Read the full update on our website: https://www.elexes.com/news-eu-mdr-transition-publication-service/

The European Commission has launched a new pilot to support Coordinated Assessments for clinical investigations and perf...
28/11/2025

The European Commission has launched a new pilot to support Coordinated Assessments for clinical investigations and performance studies.

Why this matters: While voluntary now, coordinated assessment becomes mandatory EU-wide within ~5 years after EUDAMED's clinical investigation module goes live.

Read the full update on our website: https://www.elexes.com/news-pilot-coordinated-assessment-ci-ps-update/

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Villa No. 677, Adarsh Palm Retreat, Adarsh Colony, Bellandur, Bangalore/
Bangalore
560103

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Monday 8:30am - 7:30pm
Tuesday 8:30am - 7:30pm
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Thursday 8:30am - 7:30pm
Friday 8:30am - 7:30pm

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