Preclinical testing with SMART.testing
From supply requirements to safe application: In our test laboratory, ideas mature into safe medical products. The application of novel medical technology is always carefully analysed and planned in dialogue with all parties involved (sponsor, investigators, laboratory personnel, external service providers) and with regard to the specific reason for the trial.
This results in detailed schedules, which are the basis for quality-assured, standardized processes. In the protected test environment, the application of the medical device in selected workflows in diagnosis and therapy of patients is simulated as realistically as possible and optimized in a confidential dialogue between users and developers.
Experienced clinical investigators, always experts in their medical field, advise and accompany the preclinical tests in the context of new and further development of medical technology. Use the concentrated tranquility for undisturbed research and development, surrounded by excellent medical technology and perfect equipment.
The company is DIN EN ISO 9001:2008 certified. Please feel free to compare us with other service providers.
All-encompassing - the project management
From needs assessment to implementation - quality-assured, standardised processes: Professional project management is our key to success. The company has all the necessary structural, logistical and personnel resources to successfully and on schedule handle all requirements that are the subject of preclinical trials. Our employees, like those of our external partners, are suitably qualified and are planned and deployed at an early stage in accordance with known requirements.
Our external partners are reliably involved via appropriate framework agreements, always from the planning stage to the realisation of the respective projects. Cooperation in the projects is regularly evaluated according to proven standards.Because the complexity of the respective service varies with each new project, we invest in advance in the establishment of resilient service chains.
A reliable cooperationof the individual actors will only satisfy the clients of the respective projects if this project work always functions reliably and successfully, even when dealing with the usual variances and imponderables.
Realistic - the test laboratory
A testing laboratory similar to a hospital: Medizin im Grünen operates a medical competence centre for doctors and engineers - not far from urban life and directly at the "Märkisches Meer", the Scharmützelsee in the southeast of Berlin. The best conditions for creative research and careful development await you on over 1,300 m². Concentrated tranquility allows undisturbed research and work. Take advantage of these possibilities and orientate yourself towards the well-being of the patients when developing and using medical products.
We have ten medical function rooms and four seminar rooms available for research, development and training. A modern cafeteria with a spacious terrace offers plenty of space for professional exchange. Perfect working conditions for experts and masters alike! Operate in operating theatres with state-of-the-art equipment, monitor and treat with the latest technology. Research and test with a large variety of simulation models.
Versatile - the possible applications
SMART.sim - Multimodality Simulation as a recipe for success: "See one, do one, teach one" applies to lifelong learning in medicine. Applied to the development of medical products, this means "See many, analyze all, simulate some".
In the development and approval of novel medical devices, preclinical evaluationto test safety, function and suitability for use is of great importance. This is where the later users come into contact with the product for the first time in their role as medical investigators. Essential for a successful review process - the carefully planned application in a multimodal simulation process, still in the realistic environment of a certified test laboratory.
The concept of multi-modal simulation provides a framework for the analysis and verification of the visual, acoustic, embodied and spatial aspects of direct interaction and accompanying communication in the application of the medical device. This is known to involve a very complex interaction between the trained user, the medical device and the patient.
Objective - the process documentation
SMART.avd – safe and objective process documentation: During preclinical evaluation it happens that critical events are only noted in the eyes of a few, but not all observers, there are gaps in the documentation. That means: Review of all sources, sometimes also deepening and repetition in the test laboratory.
We have made this process more efficient for everyone involved - especially in terms of invested time and costs. Our service SMART.avd allows you to improve planning and documentation in preclinical testing & evaluation.
SMART.avd iis adaptable to almost any of your needs, easy to use and reliable. State-of-the-art technology supports the preparation and post-processing of the collected data, both during debriefing on site and at any time later.
Competent - the participants
In dialogue with doctors and engineers: Innovation processes at the beginning of the development of innovative medical devices contribute to a better understanding of the future needs of users in hospitals. With this in mind, new ideas can be verified early on in confidential dialogue with experienced users in our test environment.
The final step is to specify the application idea with concrete product properties and to verify the technical feasibility. Use our modern application laboratory to concretize and further develop identified needs in the practical application of medical technology.
Our medical investigators are experts in their medical field. They advise and accompany the development cycle in everyday clinical practice and here in the test laboratory of the medical competence centre. We are in constant professional exchange with experienced experts in almost all medical fields.
Our external partners are involved on a long-term basis via corresponding framework agreements, always from the planning stage to the realisation of the respective projects. The cooperation in the projects is regularly evaluated according to proven standards. We know that it is always the sum of the big and small things that makes cooperation between all those involved possible.
You and Your team are very welcome. Visit us at an early stage, talk to everyone involved and familiarise yourself with the technical possibilities on site. For us, too, this time is ideal for getting to know each other. If we have a good understanding of you and your professional environment, then together we have a solid foundation for future cooperation. Take a look, the virtual tour awaits you.