More experts are striving for the institute.
A second cohort of the Fit for Future Program is starting. It enables manufacturers to automate and optimize their regulatory processes and increase competitiveness.
The third World Medical Device Summit intensifies cooperation between politics, authorities, notified bodies, and manufacturers. As a result, the FDA is involving us in further developing its data interface (eSTAR program).
We are supporting a notified body in the development of a REST API (data interface) that will speed up the “approval process” significantly.
Together with a notified body, we are offering a rather unknown conformity assessment procedure for manufacturers of standalone software. This will make it easier to switch to the MDR.
We are strengthening our team with more great colleagues. By the end of the year, we will have over 170 employees.
We are turning the market upside down with another product: the Fit for Future Program. For the first time, an offer specifically supports medical device and IVD manufacturers through their digital transformation. From a five-person company to a corporation with billions in revenue.
At the second World Medical Device Summit, we presented the digitalization of regulatory processes. Representatives from politics are enthusiastic and plan to involve us in evaluating the MDR and IVDR.
The Swiss Ministry of Health commissions us to develop a concept to eliminate impending bottlenecks in the supply of medical devices.
AI is finding its way into the daily work of our consultants.
We are starting to digitalize the first notified body.
The institute has continued to grow. Over 140 people work directly or indirectly for our clients.
Digitalization has taken great leaps forward. The first seven-figure order is received. Post-Market Radar and Regulatory Radar have become important pillars.
The first World Medical Device Summit takes place. Authorities such as the FDA, the EU Commission, ministries, manufacturers, notified bodies, and medical professionals come together and find concrete approaches to counter the looming gap in patient care. The state of Baden-Württemberg is offering funding of over two million euros for this purpose.
The annual "Institutstag" has now outgrown even the Council of Konstanz. It will take place for the first time in the more spacious Bodenseeforum.
After more than ten years, we are saying goodbye to the Villa Rheinburg. Our new location in the Rheingarten is ten times larger.
We exceeded the 100-employee mark.
We hired the first researchers in the field of regulatory science.
We started a partnership with Harvard.
We moved into the new Konstanz location in Rheingarten, which is three times larger.
We have played a major role in bringing corona tests to market thanks to our usability tests.
The Ministry and the German Council of Science and Humanities approved the concept for the university.
Digitalization of the approval process started in collaboration with TÜV SÜD.
Launch of new English “Auditgarant” in the USA.
“Regulatory Affairs” degree program designed and launched.
We published the Audit Guideline in English for the first time.
Start of cooperation with WHO
Decision to found a university
Some notified bodies adopt our AI and IT Security Guidelines.
First DiGA app registered with BfArM
Second Medical Device Days, taking into account all regulations – despite Corona
Establishment of the subsidiary Johner Medical GmbH: Now, we are also a legal manufacturer and authorized representative for medical device manufacturers.
Over 1500 free short consultations were provided via micro-consulting for the first time.
The year begins with a move to Turmstraße 5 in Konstanz. The premises in the technology center were too small. We are not giving up our location in Villa Rheinburg, so we are represented at two locations in Konstanz.
Once again, we are expanding our range of services:
In 2018, our further stormy development is demonstrated by the following:
Our company is growing by 100%.
We successfully pass our ISO 13485 certification on the first attempt.
We are opening our new location in Berlin.
New seminars such as the one on IVDR are complementing our range.
Every year, we substantially expand the videos in the Auditgarant. The GDPR, CSV, and clinical evaluations are in focus, as is translating over 100 videos into English.
The book on IEC 60601-1 has been written and is ready for publication and printing in 2019.
We are expanding our range of seminars:
We are once again running out of space in Konstanz. We are renting two offices in the technology center.
The "Auditgarant" is being expanded to include 50 video training courses to support the implementation of the MDR requirements and IT security.
Five additional experts are joining the team, primarily in clinical evaluation, CSV, and in vitro diagnostics.
The usability labs in Germany and the US are fully booked, and the first IT security projects for medical devices are starting.
The 12th master's program has started; as always, it was fully booked.
The exponential growth continues:
The consulting team is growing with five new colleagues.
Thanks to our new location in Frankfurt, we can reach our German customers even more easily.
We are entering into a strategic partnership with UserWorks, which will enable us to offer usability studies in the US and FDA-compliant human factors engineering documentation.
The seminar on risk management and the seminar on IEC 60601-1 complement the training portfolio and have been in high demand since the first run.
The scope of the "Auditgarant" doubles: It now also includes video training and templates for setting up and auditing quality management systems.
The German book “Usability als Erfolgsfaktor” is published in its first edition. The German book “Basiswissen medizinische Software” is published in its second edition.
We are offering our webinars as a live stream for the first time. Almost 200 listeners follow the first broadcast.
The video training courses in the "Auditgarant" are now available in English. We are also putting our professional video studio at our headquarters, the Villa Rheinburg, into operation for this purpose. Now, we can produce video training at an even faster and higher quality.
The 11th master's program, "IT in Healthcare," is, as always, fully booked.
The consulting team is also growing: Luca Salvatore has joined our team since the middle of the year.
For the first time, we are offering the internal auditor seminar.
The second MBA program begins. This time, the program includes a week in Silicon Valley, including visits to the elite Stanford University and the HMO Kaiser-Permanente.
A complete relaunch of the website, shop system, and entire e-learning platform is planned. The new video training product, "Auditgarant," will help manufacturers create technical documentation for medical devices in the shortest possible time and an audit-proof manner.
Johner Institut GmbH, which combines the institute's various business areas in healthcare IT, exists since January 01.
The consulting team continues to grow: Robert Dick-Hambeck and Markus Gerhart are now on board.
It is almost pointless to mention that the ninth study program is fully booked again, this time at the end of June. The second MBA program to start in 2014 is sold out after eight hours.
With 400 attendees, an in-house seminar on medical software development has reached a new record for participants.
Our software packages "MedPack" and "RiskPack" are developing so successfully that we decided to outsource this business branch to its own company, Medsoto GmbH, and hire a developer for it.
Many consider this year's "Institutstag" to be the best. With 170 registrations, we have reached the capacity of our villa.
As every year, a part-time master's course in "IT in Healthcare" starts in fall. It is now the eighth!
We start the new year with a premiere: The first MBA is completely sold out with 17 students. The study week at Stanford is a highlight of this program. Christian Johner's relationship with the elite university pays off.
With the German book "Basiswissen medizinische Software" (Basic Knowledge of Medical Software), we also lay the foundation for the seminar "Certified Professional for Medical Software," for which we are the first training provider to be accredited.
The new year is starting as successfully as the last one ended. In the national competition “Germany – Land of Ideas,” the institute is once again being recognized as an “excellent place” after 2007, this time for its “Healthcare IT for Africa” initiative.
The consulting services are also in such high demand that further support through ISO 13485 lead auditor Alexander Thern is both necessary and possible.
The fifth master's program is the first to start at the new Konstanz location in the Villa Rheinburg. Sven Wittorf and Corinna Hartmann joined the team to meet the high demand for study places and consulting services.
The Institute Club was created, which several companies use to provide their employees with structured training. The Institute's shop was launched to market the around 25 web-based training programs created that year, the audit guideline created at the end of the year, and the German Practical Manual "IT in Healthcare" published by Hanser Verlag in 2009. 2009 was the Institute's most successful year to date.
Almost all clinic chains, major manufacturers, and providers of products or services in the IT and healthcare sector are now customers.
The product portfolio has been significantly expanded to include webinars and seminars. As club members, customers benefit from numerous advantages.
As always, the fourth master's program is sold out.
The institute is recognized as an excellent place in the "Germany – Land of Ideas" competition. The grand ceremony will be a meeting place for the industry.
The Medical Association recognizes the master's program for the additional qualification of "Medical Informatics."
The third course starts in September – sold out months in advance.
The second study program also sold out quickly. The list of companies providing participants includes most of the major providers, and the list of speakers reads like a who's who of IT in healthcare.
Leading experts in IT management, law, communication, business administration, health economics, development, and operation of IT systems and medical statistics have been recruited.
They include the head of the Healthcare Management Institute at the University of Trier, Prof. Dr. Goldschmidt, the director of the Institute of Business Administration at the University of St. Gallen, Prof. Dr. Rüegg-Stürm, the ministerial counselor at the Federal Ministry of Health, Dr. Dietzel, and Walter Bachmann, a lawyer specializing in IT law at the law firm Graf von Westphalen, Bappert und Modest.
The course starts in September 2005 and is sold out. Enthusiastic students rate the lecturers of the first few weeks with a dream grade.
In the context of a master's program in "Pharma and Biotech Management" at the Danube University Krems, it becomes obvious how many IT projects in the healthcare sector do not lead to the desired success.
The idea is born to establish a specific university course in which experts work together with students to develop how to efficiently develop and operate IT and use it to increase effectiveness in healthcare.
The curriculum was developed, and the newly founded institute was launched under the name "Calcucare Institute" as part of Calcucare GmbH (now NephroCare), a subsidiary of Fresenius Medical Care.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
