Contact

Elexes Regulatory Consulting – Privacy Policy

Effective Date: August 18, 2025

About Elexes

Elexes Regulatory Consulting helps companies with medical device regulations and quality systems. As part of running our website and services, we sometimes collect and use personal information. This page describes what we gather, why we gather it, and how we protect it.

Information We Collect

⦿ Information from Your Visit
A few technical details are automatically picked up when you browse our website. This could include your IP address, the type of browser you use, and the pages you view. We use this data to maintain the functionality of our website and to learn how users interact with it.

⦿ Information You Share With Us

If you fill out a contact form, subscribe to updates, or reach out to us directly, we may collect details such as your name, email address, phone number, company name, or the message you choose to send. We only utilise this data to fulfil your request or offer the services you have expressed interest in.

Why We Use This Information

The information we collect helps us

⦿ Respond to questions and requests promptly

⦿ Provide our consulting services

⦿ Share updates or insights if you’ve subscribed to them

⦿ Improve our website and the way we deliver information

How We Process Your Data

⦿ We process your data based on legitimate interest (responding to communications, improving services), your consent (such as newsletter opt-ins), and when necessary to fulfill agreements with you.

⦿ In certain cases, data may be retained to meet legal or taxation requirements.

Who We Share It With

We do not sell your personal information.
We may share your data with

⦿ Trusted service providers, such as email platforms or cloud storage services, are always under strict confidentiality agreements.

⦿ Legal or regulatory bodies, if required by law or to fulfill our obligations.

Your Choices and Rights

Depending on where you live, you may have the right to:

⦿ Ask for a copy of the information we hold about you

⦿ Request corrections if something is inaccurate

⦿ Request that your information be deleted, unless there are legal reasons why we must keep it.

⦿ Limit or object to how we use your information

⦿ Withdraw any consent you have previously given

Please get in touch with us at  jennifer@elexes.com to exercise any of these rights.  Before completing your request, we might need to confirm your identity.

How Long We Keep Your Data

⦿ Contact Forms / Website Interactions: Retained only as long as needed to respond to your requests.

⦿ Client Records: Retained during our engagement and up to 6 years afterward, for legal or tax purposes.

⦿ Usage Data: Aggregated or anonymized after a short period.

Security of Your Data

To protect your data, we uphold the proper organisational and technical safeguards (such as access controls and encrypted communication).  Please be aware, though, that no system is 100% safe.

Cookies & Tracking

We use cookies to:

⦿ Keep the website functional and improve user experience.

⦿ Analyze how the website is used (e.g., which pages are visited most).

Through your browser’s options, you may modify your cookie choices. Be aware that your experience may change if you disable cookies.

External Links

There may be links to external websites on Elexes’ website. Their privacy policies and content are not our responsibility. Please review their own privacy policies when visiting.

Policy Updates

This policy may be updated periodically. Any modifications will be noted on this page along with the updated effective date. Continuing to use our site or services after changes indicates your acceptance of the updated terms.

International Data Transfers

Since Elexes works with clients and partners across different countries, your information may be transferred outside the country where it was collected. When this happens, we make sure appropriate safeguards are in place, such as confidentiality agreements and secure systems, to keep your information protected, no matter where it is handled.

Contact Us

Please contact us with any queries, worries, or requests regarding this privacy statement.

Email: jennifer@elexes.com

Mailing Address: 

30 N Gould St Ste R Sheridan, WY 82801 (USA)
Adarsh Palm Retreat, Bellandur, Bangalore, 560103 (India)

Looking For Regulatory Assistance?

Let's Talk How We Can Help You?

Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
img
We’ve More
Than 256+ Global Clients
The Best RA & QA Consultants

Clients Testimonials

Amazing Feedback About Our Services

image

Tom Birney

CEO Masterlink, Arizona

“ Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms “

image

Diane Bryant

CEO Novasignal, Los Angeles

“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. “

image

Daniel Kinsey

President ViDava, Florida

“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice. “

image

Linda Pan

Sr. Exe Treedental, Hong Kong

“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. “

image

Joshua Mink

Manager Outset Medical, California

“Highly recommend Elexes! They always meet commitments and follow through on action items. “

image

Michal Depa

CTO Jana Care, Massachusetts

“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly. “

image

Philip McFerran

MD Blackrock Pharma, England

“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. “

image

Samip Shah

VP Regulatory AliveCor, California

“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. “

image

Elizabeth W

Owner Liz Inc., Arizona

“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time. “

image

Kurt Sysock

CEO Radformation, New York

“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation! “

Latest News & Blogs

Read Our Latest Articles

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
Post a Comment

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices

Team Elexes
Read More
Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
Post a Comment

Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights

Team Elexes
Read More
Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes
Post a Comment

Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes

Team Elexes
Read More

Latest Portfolio

Modeling degradation kinetics of biomedical polymers used in implantable medical devices through hydrolysis, oxidation, and Arrhenius-based modeling

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
FDA updates Pre-RFD guidance with new recommendations for medical device, drug, and biologic classification.

FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
FDA Draft Guidance on QMSR for Premarket Submissions

FDA Issues Draft Guidance on QMSR Information for Premarket Submissions
Notified Bodies Warn Shortage Could Hinder AI Regulation

Notified Bodies Warn Shortage Could Hinder AI Regulation
MHRA CEO Highlights Risk-Proportionate Regulation for AI & Medical Devices

MHRA Plans Risk-Proportionate AI and Medical Device Oversight
MedTech industry experts discussing proposed reforms to MDR and IVDR regulations.

MedTech Industry Urges Comprehensive Reforms to MDR and IVDR
Illustration showing AI technology and FDA evaluation concept for medical devices

FDA Seeks Feedback on Real-World Performance of AI Medical Devices
FDA’s ASCA program helps medical device makers streamline compliance and submissions.

FDA’s ASCA Program: Transforming Medical Device Compliance
AI and regulatory trends shaping the future of inflammation imaging in healthcare

Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
MedTech downsizing guidance ensuring compliance with Elexes

Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes
FAQs on EU Medical Device Regulation

FAQs – EU Medical Device Regulation (EU MDR 2017/745)
Comprehensive guide to medical device testing for safety and regulatory compliance

Medical Device Testing Requirements: A Complete Guide
When is a new 510(k) Submission Required as per the FDA

When is a new 510(k) Submission Required as per the FDA?
510(k) Submissions in 2025: Key Updates and Insights

What’s New for 510(k) Submissions in 2025? Key Updates and Insights
Navigating FDA Cybersecurity in Medical Devices Simplifying Documentation and Compliance

Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance

Need Any Help? Or Looking For an Agent

9806071234
sendmail@example.com
Working Hours : Sun-monday, 09am-5pm
© 2024 Elexes. All Rights Reserved.