Dear visitor,
after a four-year transition period, MDR Legislation (Medical Device Regulation) is mandatory in Europe for all stakeholders as of May 26, 2021. In addition, transition periods apply e.g. for placing medical devices on the market until May 26, 2024.
The new regulation initially generated a wide range of questions with some stakeholders. What does the new regulation require? Does it result in an increased documentation effort, in combination with increasing cost? Do the „notified bodies“ have sufficient capacities to ensure timely certifications for all stakeholders?
The MDR has a strong focus on the medical benefit and clinical relevance for patients. Specific questions are addressed, such as: Which added value do these products have? Is there prove of a clinical relevance? Do companies have an established QM system? How is the post-market surveillance process structured?
In retrospect, IEM considers MDR to deliver a significant added value for medical products and an even greater benefit for IEM as a company.
Triggered by the new regulation and combined with a binding deadline, literally no stone was left unturned at IEM over the past two years. All internal and external procedures were critically scrutinized across all departments and reviewed in regards to optimization. The analysis was based on the credo: are our procedures, products and services smart? Do they generate real added value for our customers? And can we meet the high quality standards we have set ourselves?
IEM has invested heavily in its staff members in order to be prepared for any future challenge in the medical device market associated with the MDR, such as the ongoing digitization of healthcare, the increasing importance and transmission of big data and the increased use of artificial intelligence and algorithms.
The entire team at IEM makes its contribution every day so that in 2022 the longed-for MDR certification can be issued by a „Notified Body“ and thus a long and rocky road towards a completely changed and „better“ company can be completed.
But even a successful MDR certification will ultimately be just another milestone on IEM‘s path to providing the best possible products, the best possible services and the best possible care to its customers, anytime, anywhere.
Our claim „on life‘s side“ now fits even better than ever before.
Thomas Korth (CEO)
Company
IEM is a researcher, developer and manufacturer of validated medical devices and services, specializing in the field of cardiovascular diseases. The medium-sized family company based in Aachen has been in existence for over 25 years and is one of the leading providers in the premium segment internationally. As an international technology expert for hypertension management, IEM offers complete solutions in the areas of screening, diagnostics and follow-up management.
In addition to these core products, the focus is on eHealth - an efficient therapy and compliance management of vital data recorded at home.
History
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1993
Founding of the family company Industrielle Entwicklung Medizintechnik GmbH by Martina Hillemanns-Korth and Uwe Korth in Stolberg, Germany -
1996
Outline of an initial eHealth concept
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1998
Launch of the wrist blood pressure measuring device “Klock”
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2003
First eHealth presentation at CEBIT
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2007
Launch of Hypertension Management Software “HMS CS”
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2007
Launch of the long-term blood pressure measuring device “Mobil-O-Graph® NG”
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2009
Launch of the long-term blood pressure measuring device with individual pulse wave analysis “Mobil-O-Graph NG” + “PWA Dongle”
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2011
Expansion of product range to include the agedio screening service “agedio B900” & “agedio K520”
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2011
FDA approval of Mobil-O-Graph® PWA
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2014
Launch of the telemetric home blood pressure measuring device with Bluetooth transmission “Tel-O-Graph® BT”
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2016
Launch of the telemetric home blood pressure measuring device with GSM transmission “Tel-O-Graph® GSM”
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2017
Launch of the eHealth transmission modem “eConnect®”
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2018
25-year company anniversary
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2019
Launch of the screening system “agedio® B700”
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2020
Rebranding
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1995
Launch of the first long-term blood pressure measuring device “Mobil-O-Graph®”
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1996
Production of the first own-brand labelling product
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2002
Launch of the first home blood pressure measuring device “Stabil-O-Graph®”
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2004
Launch of the first home blood pressure measuring device with Bluetooth transmission “Stabil-O-Graph® mobil”
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2007
FDA approval of Mobil-O-Graph® NG
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2009
Launch of the ECG recorder “BEAM”
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2010
Launch of the long-term blood pressure measuring device with 24-hour pulse wave analysis “Mobil-O-Graph PWA”
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2011
Launch of the telemetric scales “Libr-O-Graph”
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2014
Thomas Korth joins the family company
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2016
CFDA approval of Mobil-O-Graph® NG and Mobil-O-Graph® PWA
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2017
Launch of the screening system “agedio® B500”
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2018
Renamed to “IEM GmbH”
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2019
Sales in over 95 countries worldwide
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2019
FDA approval of Tel-O-Graph® BT
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2020
Completion and relocation to own company building
STRUCTURE
Research
Intensive research is the central pillar of many years of successful business. To this end, IEM intensively collaborates with universities, research institutions and Key Opinion Leader around the world. The
results of scientific projects are an essential element of the development of our products.
Development
Based on the results of intensive research, we develop innovative inhouse solutions in line with the high standards regarding quality, longevity and usability. With careful usability engineering, documentation and continuous functional checks, we develop series-production ready products that offer maximum value. Alongside IEM-branded products we also develop products made to order (e.g. OBL).
Production
As an ISO-certified company, we care about offering only products of the highest quality, which is why we monitor every process step in accordance with defined standards at our in-house production facility – living up to the excellent reputation German engineering enjoys. In times of high capacity usage, we can meet your demand with short lead times thanks to our ability to scale flexibly.
Sales
Our aspirations also include ensuring quality in the sales process. This means that we provide you with direct access to experts within IEM for each field and target group. Our products are sold domestically as well as internationally through certified medical device retail partners who receive training and regular audits for quality control purposes. This allows us to guarantee that you receive the same standard of service and support around the world, from sales advice to product repair.
Competence of our area sales managers
Johannes Risse
North-America
johannes.risse@iem.de
(+49) 241-41259-341
Kevan White
South-America and Iberic
kevan.white@iem.de
(+49) 241-41259-330
Michelé Schmitz
Germany, Austria and Switzerland
michele.schmitz@iem.de
(+49) 241-41259-354
Kilian Gobiet
Europe
kilian.gobiet@iem.de
(+49) 241-41259-352
Kevan White
Asia/Pacific and Africa
kevan.white@iem.de
(+49) 241-41259-330
COMPLIANCE
Data security and Data management
Innovative medical solutions must be safe and reliable while also offering significant medical value. Not only that, but they also need to be adapted to customer and product-specific needs by enabling interoperability. These standards are especially important when it comes to the transmission of health data. This is why these requirements constitute the basis of all IEM systems. The collection and transmission of measured values is strictly anonymous, with security being provided by apps, modems and GSM modules, which are integrated in measurement devices and approved as medical devices.
Together, they constitute the core of the data management system alongside the IEM gateway server (medical product). The powerful and failsafe gateway server processes data in line with the highest security standards and transmits it in encrypted form and anonymously to IEM solutions or, if so desired, to the customer’s own databases in any standard format.
In addition to maximum data security, the gateway server in conjunction with the IEM transmission units enables the development of new, interoperable systems to allow optimised patient care.
Gateway-Server
- Redundant server systems
- Server monitoring with status report
- 99,9% system availability
- Data received exclusively from registered senders
- Anonymous and encrypted data transmission
- Medical product
- ISO 27001-certified server provider
Quality management
Our products and services are developed in accordance with international standards and undergo extensive testing in line with specific and relevant standards: within our company, by independent testing institutions and under the critical eye of internationally renowned clinics and clinical research organisations.
Our software and system development process encompasses the entire product development process from drawing up the medical product specifications to clinical testing. Together with our customers, we efficiently develop innovative solutions and incorporate requirements in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 80601-2-30.
Quality requirements (according to ISO 13485 and ISO 9001) are integrated into the development process from the outset as a matter of course. We apply these standards to systematically achieve the best customer and patient satisfaction possible with respect to our devices and services.
Certificates
SERVICE
Communication
Our employees are available via a diverse range of communication routes. In addition to traditional methods such as e-mail, telephone and fax, our staff will also be glad to assist you personally via online chat, video conferencing or in face-to-face meetings. We also offer the option to monitor the status of orders and deliveries online and in real time.
Response time
Your needs have absolute priority for us. We usually answer queries and concerns on the same day, and always at least within 24 hours. When contacting our staff via online chat, they will also respond to your enquiries within an average of 10 seconds.
Repair service
Your device will be maintained and repaired personally in-house in accordance with high quality standards. While the device is being inspected or repaired, you have the benefit of loan devices that allow you the benefit of uninterrupted use. All repairs are performed within 24 hours. The status of the device inspection, repair and delivery tracking can be viewed online at any time.
We are a member of
