What drives us: Our Mission
1. Objective: help companies to develop safe medical products without developing quality management overhead
Fewer unsafe medical devices: Almost daily the Federal Institute for Drugs and Medical Devices publishes reports on risks posed by faulty software. This is the second most common reason for recalls by the FDA. At the same time manufacturers of medical products such as medical devices and clinical information systems complain about more and more regulations (standards, laws, directives, regulations, etc.) and are afraid of audits and inspections.
Fewer unnecessary QM burdens: We understand ourselves as “Developer understanders” and “QM purgers”! Our greatest joy is to assist medical device manufacturers, not just to survive the next audit quickly and safely, but also to develop, in a short amount of time, a high quality and safe medical software.
Create opportunities for small companies, relieve large companies: Our concern is to enable small businesses to master the regulatory hurdles and to be able to bring their innovative products on the market. It is equally our concern, to return the employees of large companies with the joy and power of innovation, which are crushed by a senseless QM overhead.
For this we offer individual advice and tailor-made tools, checklists, seminars and e-learning units. Manufacturers benefit from our experience, we have gained both as a developer of medical software, as well as an instructor of notified bodies.
2. Aim: to promote professional and personal development
We think our education system is unfair: Access to education is correlated, just like only a few other countries in the world, with the educational level of parents. Therefore, we have found an authorization procedure with the Danube University, which gives access to the master program not only to graduates but also to experienced practitioners.
We feel that the level of most continuing education courses is too low: For many learning has become something through which one must “pass through.” Boring classes in the form of tedious film battles is not how we do it. For they are not only boring, but are of little use in the professional life.
Our aim, however, is to make learning something tangible, which brings joy. We learn in small groups of about 17 participants, in an atmosphere of curiosity, of trying new things and of community. With the aim of not (only) the knowledge, but above all the aim to improve the skill.
We think the training offer is inadequate: We’ve even searched for years for an in-service training in which you learn to develop IT solutions for healthcare, to operate and use. We did not find anything and therefore we have launched the master’s degree programs and seminars which are tailor-made for medical device manufacturers at the Institute. They have long been a great success – for us, but above all for the participants, who could start wonderful careers.
Certification program “Certified Professional for Medical Software” aimed specifically at people who develop medical software, operate and “allow”, we contributed significantly and were the first accredited training provider.
3. Target: Enable IT for better healthcare
We wonder with which inefficiency healthcare is often operated, how money is wasted, and why the commitment of nurses and physicians is partially ineffective.
We help manufacturers to develop a contemporary and usable IT that supports the work of the medical staff and is not complicated. We teach the staff in hospitals (responsible for IT and medical technology, doctors, nurses), in courses, seminars and e-learning to adapt, operate and use IT safely and effectively.
4. Objective: provide jobs worth living for
Much of what we want to achieve for our customers, are also targets for ourselves: We create jobs that offer our team the freedom to grow, learn and creatively design. Workplaces that are safe and where compatibility does not remain an empty slogan with the family. These jobs have human attachments that are where passion, expertise, empathy, and integrity were predestined.