New Sales Partner Agreements for our EEA partners

In less than a month, on May 26, 2021, the new European Medical Device Regulation 2017/745 will finally come into effect with one year delay. This new regulation affects many aspects of the regulatory landscape surrounding medical devices. One of these aspects are the so-called economic operators.

The authors of the MDR have taken a good look along the typical supply chain that brings a medical device from the manufacturer to the customer, a healthcare institution, medical professional or a patient. But they have not stopped at identifying these economic operators. They have also assigned obligations that each of them must fulfill to ensure that only safe and effective medical devices are brought and kept in the market.

While the currently still applicable Medical Devices Directive 93/42/EEC stresses the importance of the manufacturer, the authors of the MDR have realized the significance also of the distributor. As a result, the MDR assigns a number of obligations also to the distributors of medical devices.

These obligations include:

• Verifying the compliance of medical devices and ensuring the traceability of every device delivered to customers
• Active participation in vigilance activities, incl. reporting of suspected incidents, supporting device recalls and field safety corrective actions etc.
• Collecting, documenting and reporting of non-conforming devices, complaints and suspected incidents and feedback
• Monitoring of local legal and regulatory changes
• Participation in medical device training with learning success control (ISO 13485:2016)
• Translation of Instructions for Use, graphical user interfaces and labeling materials into the local authorized language(s)
• Cooperation with the competent authorities
• Enabling IMAGE to carry out audits to ensure the distributor’s compliance with the regulations

What are the consequences?

It was time to review our current sales partner contracts in the light of the new MDR. And we concluded that, in their current form, they do not meet the new regulatory requirements. But, we are convinced of the importance of putting our relationship with all our sales and service partners in the European Economic Area on a solid legal footing.

Therefore, we have revised and updated our sales partner agreement to include the new obligations. Throughout the months of April and May, we will contact each of our EEA partners to discuss our future relationship and offer them an MDR compliant contract.

If you have not yet heard from us, feel free to contact your IMAGE sales rep at sales@image-systems.biz.

Turning DICOM SR into printable radiology reports with iQ-SR2PDF CONVERTER 1.2

Documenting diagnostic results and medical findings in so-called structured reports (SR) has evolved into the gold standard in radiology. Thus, the DICOM SR is gradually replacing the traditional report dictated by the radiologist using voice recognition or transcribed later by a transcriptionist, both requiring subsequent verification.

The emerging of DICOM Structured Reports has significantly improved diagnostic report communication. They are readable by medical information systems worldwide and lead to a much better report turnaround time.

But outside of the radiology department, referring and treating physicians still rather prefer to receive the results for the procedures they sent their patients in for in a PDF or paper format.

This has led us at IMAGE to the question: How can we combine the efficiency of a DICOM SR with the traditional expectations of receiving a radiology report in letter form without creating additional overhead?

Our solution: iQ-SR2PDF CONVERTER 1.2

We are pleased to announce this new tool in our product portfolio. This smart application automatically converts DICOM Structured Reports into customizable PDF files and copies the content of the SR and the patient demographics into a document that comes with the healthcare institution’s letter head, logos, text formatting and even with digital signatures of the involved physicians. All this can be done by using predefined Microsoft Word templates. The created PDF reports are encapsulated with a DICOM shell, that allows to store them in the PACS together with the studies to which they belong and to share them across DICOM networks. The PDF reports can also be downloaded and printed, sent to the referring physicians or handed out to the patients.

Here is what you can do with iQ-SR2PDF CONVERTER:

• Automatically transform DICOM SR into DICOM PDF
• Create your report templates per imaging center (institution), radiology reading group (reading entity) or radiologist (reading physician)
• Manage the PDF reports for referring physicians in any PACS
• Share reports via multiple DICOM targets (using iQ-WEB)
• Digitally sign the reports by adding single (verifier) or dual signature (verifier and observer)
• Use patient ID barcodes (EAN-13 and UPC-A supported)

To find out more about iQ-SR2PDF CONVERTER, check out this flyer or our website. If you want to give it a try, you can download a free 30-day trial version in our Download Center.

Hint: iQ-4VIEW - how to see tissue density in CT images under the mouse pointer

For the evaluation of images, the density of tissues plays an important role. These values can provide conclusions about tissue types and can assist in the detection of pathological deviations. This is especially used in CT images, where such information is given in so-called Hounsfield units (HU).

While iQ-4VIEW offers several measurement tools for the calculation of density in specific areas, there is also an easy way to determine the density value of an exact point or pixel.

iQ-4VIEW can display these density values in CT images directly without the user having to select a measurement function first.

How this works exactly depends on the mode in which iQ-4VIEW is used:

• In client mode, this value is displayed and updated automatically with every mouse movement.
• In server mode, the user needs to click into the intended area in the image in order to get the density information.

iQ-4VIEW shows the calculated value in the left middle of the respective view in the image processing area.

Arab Health: Looking forward to seeing you in person

Even more than a year after the SARS-CoV-2 outbreak, the world is still dealing with the ongoing pandemic. Important medical trade shows have either been canceled or were switched to a virtual exhibition concept. We are happy that we are now able to attend our first onsite event in quite a while and look forward to meeting you in person at the Arab Health 2021 in Dubai.

Come and visit us between June 21-24, 2021, at booth S1.K34, when we showcase our latest RIS, PACS, VNA and cloud solutions:

• iQ-RIS: Affordable and smart radiology workflow manager
• iQ-WEB RIS: Radiology workflow manager from scheduling to reporting from anywhere
• iQ-WEB: All-inclusive PACS/VNA for storing, viewing, distributing and archiving medical imaging studies and reports
• iQ-WEB Portal: Easy, quick and safe access to medical records for referring and treating physicians
• iQ-WEB UPLOADER: Web portal for secure data sharing (complementary prerequisite for teleradiology and telemedicine)
• iQ-4CLOUD: On-demand and reasonably-priced PACS/VNA
• iQ-DOSE: Automatic monitoring, processing and documenting of radiation doses

If you would like to schedule an appointment with us, please fill out our contact form.

See you in Dubai!

Law and order: Meet our QM and RA teams

As a sales partner, you usually do not get in contact with our Quality Management and Regulatory Affairs teams as much as you do with our sales representatives and support specialists. However, the work that both departments do is equally important as they ensure that the solutions you buy have been properly assessed, certified and registered.

Come and meet the members of our QM and RA teams:

Mathias Doliwa - Quality Management Representative
Mathias has been watching over our quality management system for over 2 years now. He is continuously searching for ways of improving our processes and makes sure that necessary measures are implemented. He not only enjoys keeping our QM system in shape, but also his garden, where he likes to spend time with his wife and kids.

Sabine Urban - Quality Management Specialist
Sabine joined IMAGE seven years ago as part of our marketing team. Later on, she branched out into the Quality Management area, where she is assisting our QMR, ensuring that our high quality standards are met in everything we do. In her spare time, she likes to leave process flow charts, role descriptions and external audit preparations behind with some relaxing yoga workouts and quality time with her family.

Sabine Stridde - Team Leader Regulatory Affairs
Sabine is one of IMAGE’s very first employees and has successfully coordinated the product development of iQ-VIEW and other image processing software for many years. Since 2019, she tries to keep track of all the medical device laws and regulations and watches over their compliance but also assists our partners in accomplishing international registrations. As a respite, she spends her leisure time doing creative things, such as drawing and photography.

Kay Wegner - Technical Author
In October 2018, Kay came on board and has been strengthening the IMAGE team ever since. As a technical author, he is primarily responsible for writing and maintaining the user documentation for our products, thus, keeping in close touch with our Development team. In his spare time, he plays piano and guitar in his music projects, likes to travel and is interested in foreign languages and cultures.

Cathleen Mildebradt - Technical Author
Cathleen has been with us for more than 13 years and has earned her laurels in our marketing department. In January of this year, she joined the RA team as a technical author, where she brings to the table her advanced marketing experience and her linguistic finesse. When not making our products sound like the one thing you simply cannot do without, she can be found enjoying quality time with her family and playing with her kids.