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

Elexes Medical Consulting Pvt Ltd

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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.

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! ✨

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/

22/01/2026

The TGA has clearly outlined how medical devices must be imported and supplied in Australia.
Whether you’re a manufacturer, supplier, or healthcare professional, understanding this process is key to staying compliant.

Read more: https://www.elexes.com/news-importing-and-supplying-medical-devices-australia-tga-2026/

01/01/2026

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

25/12/2025

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

18/12/2025

The FDA has launched the TEMPO pilot program to support earlier access to digital health technologies for chronic diseases - while still ensuring patient safety.
A noteworthy move toward modern, real-world-data-based regulation.

Read more: https://www.elexes.com/news-fda-launches-tempo-digital-health-pilot-chronic-disease/

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/

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/

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/

20/11/2025

The FDA has issued updated guidance on the Pre-Request for Designation (Pre-RFD) process - a preliminary assessment for sponsors developing drugs, devices, or combination products.

What’s new? The guidance makes the process more transparent, clarifies what information sponsors should provide, and helps reduce regulatory uncertainty.

At Elexes, we’re following these changes closely to help you stay ahead.

13/11/2025

Big Changes Coming for Medical Device Manufacturers!

The FDA just released new draft guidance on Quality Management System requirements for PMA and HDE submissions. Here's what you need to know

Key Areas to Focus On:

Risk-based decision making throughout product lifecycle
Design controls with full traceability
Process validation before preapproval inspection
Supplier management and controls
Enhanced record-keeping requirements

Important: This applies to PMAs and HDEs, NOT 510(k)s!

What are your biggest concerns about implementing these changes? Drop a comment below!

Address

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

Opening Hours

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

Telephone

+917899544400

Website

http://www.elexes.com/

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