On Oct 31st, 2016 BSI officially affirmed that Melmedtronics operates its Quality Management System in compliance with ISO13485
for “Design, development, manufacturing and distribution of mobile software applications and devices for audiology assessment of hearing.”.
Marshall Wenrich, COO, restated that Melmedtronics is committed to enhancing it Products under full Design Controls for its entire International customer base.
“This is the next step in finalizing our product registrations with Health Canada and meeting regulatory requirements for CE Mark. That combination will unleash all our established Distributors across a constantly expanding global marketplace.”
Dr. David Holmes, CEO at MelMedtronics
Melmedtronics already has international installations or trials in process across 32 countries outside the United States on six continents.
“The software technology used to develop our iAudiometer and Tele-iAudiometer allows us to easily accommodate localization requirements including language options, labeling and unique regional processing subtleties. And of course the base tone generation engine of all our products is already calibrated to the accepted international ANSI Standards (ANSI S3.6) and ISO-EN Standards (EN60645)”
Dr. Gianna Lardaro, CPO at MelMedtronics
Anyone requiring additional information about Melmedtronics’ ISO13485 Quality System or regulatory status in various countries can contact firstname.lastname@example.org
Interested in becoming a Distributor in Melmedtronics global footprint, send email to email@example.com
Our previously announced beta-testing for Tele-iAudiometer™ at multiple International sites including 32 countries outside the United States on six continents has concluded with a lot of field usage data, some great suggestions that have already been incorporated and more recommendations that will appear in future software releases.
We thank all our participants for your huge enthusiasm and active engagement!
Therefore, Melmedtronics is announcing International (ex-USA) commercial availability of the Tele-iA Product starting July 29th for all continents other than North America.
Marshall Wenrich, COO, explained the launch strategy:
“We still have significant beta-site testing ongoing in the United States with Government agencies and very large Clinic operators. All of those sites are actively contributing to tele-iA refinements for those target markets, however the ultra-low cost of initial entry to gain diagnostic access to traditionally unreachable locations has resulted in our international Distributors pleading for access to the Commercial Product version.”
“The introduction of ISB-mini as an extremely light weight functional equivalent that replaces our Standard ISB in a much smaller package enables our initial tele-iA Product launch for highly mobile environments. And unlike the manufacturing production problems that slowed iA System deliveries during second quarter this year, ISB-mini is available in quantity right now.”
Tele-iA is sold as a highly-configurable ‘service’ with an upfront initial equipment cost and monthly fee for the features provided. According to Dr Gianna Lardaro, CPO,
“Tele-iAudiometer comprises two software components on two separate platforms: one on the Doctor Site acting as a remote controller, and one on the Patient Site acting as the audiometer. The latter uses the same proven engine of iAudiometer so it is also calibrated to ANSI Standards (ANSI S3.6) and ISO-EN Standards (EN60645): this makes Tele-iAudiometer a full diagnostic tele-audiology system where a single Clinician device can operate equipment at multiple (remote) Patient sites.“
Many philanthropic organizations have been the perfect outreach mechanism to validate remote usage and have independently documented benefits from using the iAudiometer technology during mission trips.
©Copyrights Hear The World Foudation
“Hear the World volunteers were able to complete the free hearing tests, thanks to donated Insert ear phones and iPad software [….]the iAudiometer testing software for the ear conduction screenings at the public health fair. ”
For Tele-iA pricing in your specific region, contact your Distributor or Melmedtronics directly for a customized quotation. There are no long-term contracts and the selected services may be adjusted through the Melmedtronics’ customer web portal on a monthly basis to optimize the return on investment as needs change.
MelMedtronics announces the worldwide release of its beta Tele-iAudiometer™ iOS app.
This is the world’s first Tele digital audiometer on mobile devices that includes video communications, a full range of audiological tests, and built-in analytics.
“This Is An Exciting Opportunity For Audiologists To Economically Enter The Telehealth Space Using Our Tele-iAudiometer Solution With A Customizable Suite Of Options.“
Jon Putman, VP Sales at MelMedtronics
Our Telemedicine system will allow Audiologists to complete hearing exams remotely without geographic boundaries”
Dr David Holmes, CEO at MelMedtronics
The company is currently enrolling beta sites now through April 11th
to immediately start using the Tele-iAudiometer system in their practice, in exchange for providing valuable insights back to MelMedtronics design team prior to the mid-Q2 2016 official product launch.
Interested parties wanting to innovate within their facility or practice should contact MelMedtronics VP of Sales, Jon Putman at firstname.lastname@example.org
MelMedtronics announces completion of its medical device registration with FDA. The product line is showcased by the world’s first Tele digital audiometer on mobile devices, Tele-iAudiometer that includes video communications, a full range of audiological tests, and built-in analytics.
“We are able to highly leverage our proprietary software platform approach for Telehealth to economically create targeted products with a Customizable Suite of Options. Although the initial products are iOS-centric, we are in the process of down-selecting a set of EHR systems from which we can import/export patient and doctor information directly, including supporting the industry standard NOAH format.“
Gianna Lardaro, Chief Products Officer at MelMedtronics
The establishment registration and full list of products is available on the FDA website by clicking the following link:
Establishment Registration & Device Listing
“The FDA Registration is a big step forward For MelMedtronics.
We also have a pending Application for Health Canada and are in the process of renewing our ISO:13485 and our CE Mark for the EU!“
Dr. David Holmes, CEO at MelMedtronics
For more information on testing or acquiring our products, interested parties should contact MelMedtronics VP of Sales, Jon Putman at email@example.com.
Audiology Infos Italia published the announcement of its Melmedtronics looking for beta testers for the revolutionary tele-audiology system: Tele-iAudiomter.
Click here to read the article
MelMedtronics is very proud to announce that Marshall Wenrich has been appointed as Chief Operating Officer.
Mr. Wenrich said:
“I am so impressed that Melmedtronics has launched this specialized area of diagnosis and treatment into the 21st century through an effective use of modern technology. MelMedtronics is riding a huge industry trend and I’m grateful to have the opportunity to join with them in furthering that ambition!”.
Mr. Wenrich will be focused on scale-up of the entire organization including overseeing the day to day operations of the company, improving operating procedures to allow the company to serve multiple diverse end customers, supporting Marketing/Sales in the dissemination of the unique Melmedtronics’ Brand, and coordinating use of funds to advance other product development initiatives. MelMedtronics believes the addition of Wenrich rounds out the mangement team and will leverage his significant medical device history to accelerate company growth.
More about Marshall Wenrich (Visit his LinkedIn Profile)
Marshall is a Technology-oriented operations Executive with a 24-year history serving as CEO/COO, Management Consultant, or Board Member in support of growth plans leveraging innovation to significantly increase company valuation. As an active member in the NACD continuing education program, Marshall has identified how his experience operating and growing high-tech companies can be integrated with existing Board of Directors/Advisors as an independent, yet practical perspective. He has personally worked with more than 200 companies on products across medical, avionics, information technology, communications and industrial control ranging from start-ups to Tier 1 stalwarts.
Marshall received his BS in Engineering at Lehigh University and MS in Engineering at University of Texas.