Testing of medical devices - safe and transparent


Services for manufacturers of medical technology

From supply requirements to safe application


Welcome to Medizin im Grünen, your medical competence centre just outside Berlin. In our testing laboratory, ideas mature into safe medical products : Applications are simulated in a protected test environment and optimised in a confidential dialogue between users and developers. Here you will meet renowned physicians who are committed to safe medical devices by sharing their experience and skills.

Take advantage of the concentrated peace for undisturbed research and development, surrounded by excellent medical technology and perfect equipment. Our physicians, partners, suppliers and the staff of Medizin im Grünen meet you with maximum attention and commitment.

Quote Hermann Hesse:

"The impossible must always be tried in order to achieve the possible".    

Sincerely, your Dr. Heiko Ziervogel

 

The measures adopted by the European Commission to improve the safety of medical devices increase the requirements for manufacturers of innovative medical devices. If society demands more transparency about the use and application of the new technologies, then open dialogue is needed not only to check the safety, but also to prove the benefits of medical devices.

 

 

Phase 1: From the idea to the prototype


More than half of the ideas for new products come from their users, doctors or nurses, especially the so-called breakthrough innovations.

In the early research phase, manufacturers seek cooperation with hospitals and universities. The aim of the cooperation is to gain and transfer technology, often for concrete future products.

Within the product development phase, there are formalized processes that ensure the early involvement of customers in the development process.

Special innovation processes help to ensure that the processes and future requirements of customers are correctly understood.

At the end of the entire idea process there is the specification of the application idea with product properties and the verification of the idea for its technical feasibility.

The best ideas come from everyday life, from doing regular things. Use our modern possibilities to specify requirements in practical application and to apply new ideas at an early stage, in the safe application laboratory, preferably as a patient substitute model.

 

 Phase 2: Development to market approval


Phase 3: Market launch until reimbursement


The success of patient care with medical technologies is the result of the interplay of many factors - a good product, well-trained doctors and patients who act responsibly.

The important role of the user is one of the main differences to the pharmaceutical sector. For this reason, the training and further education of physicians and surgeons is of particular importance, particularly in the case of more complex medical technologies.

The Medical Devices Act stipulates that medical devices may only be operated or used if they have no defects that could endanger patients, employees or other persons. This applies to the initial commissioning as well as to any further application.

A practical training of the personnel of the manufacturers is indispensable for the responsible training of the users, in particular with more complex medical technologies. Modern basic, advanced and advanced training for physicians and nursing staff, geared to current requirements, creates the basis for the safe use of medical products.

Phase 4: Market Surveillance


Monitoring the safety and performance of medical devices over their entire life cycle is one of the most important tasks in establishing and maintaining quality management systems for medical device manufacturers (DIN EN ISO 13485:2012 standard). Various authorities monitor compliance with the Essential Requirements and quality assurance measures.

 

The Medical Devices Act stipulates that medical devices may only be operated or used if they have no defects that could endanger patients, employees or other persons. This applies to the initial commissioning as well as to any further application.

Manufacturers, operators, users and distributors of a medical device are obliged to immediately report incidents, i.e. product-related undesirable events, to the responsible higher federal authority, the Federal Institute for Drugs and Medical Devices (BfArM).

The evaluation of defects and risks requires close monitoring by manufacturers and users.  Measures to eliminate the existing risk in clinical application also include the rapid validation of these observations in suitable test laboratories, possibly also in patient replacement models that have already been validated as suitable in development.

 


Quelle:Der lange Weg eines Medizinproduktes von der Idee bis zur Anwendung am Patienten, BVMed

 


Contact

Call us on: +49 33679 429810

Or write to us: Contact

Medical Center of Excellence
c/o HCx Consulting GmbH
Ulmenstraße 12
15864 Wendisch Rietz

 

Impressions

develop and TEST MEDICAL PRODUCTS