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
Secure pre-clinical testing with SMART.avd
During pre-clinical evaluation , it happens that critical events are only noted in the eyes of a few but not all observers, which results in gaps in documentation. That means: review of all sources, sometimes also deepening and repetition in the test laboratory.
This process had to be made more efficient for everyone involved - especially with regard to invested time and costs. This is how SMART.avd came about, with the aim of improving planning and documentation in preclinical testing & evaluation.
The service is 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.
Learning from experience
In the development and approval of novel medical devices, preclinical evaluation to test safety, function and suitability for use is of great importance. This is where the subsequent users come into contact with the product for the first time. Essential for a successful process - the carefully planned application, with the best available simulation model, still in the realistic environment of a certified test laboratory.
The focus is on confidential dialogue between all those involved. A lot to think about, even more to do - plan, check, test and evaluate. Decisive for success: the all-encompassing, professional documentation of all activities and results.
The solution - SMART.avd
We have approached our customers and partners and have repeatedly asked what conditions must be met from the auditor's perspective for successful documentation. The following criteria emerged from the dialogue:
SMART.avd - the four phases of pre-clinical testing
With SMART.avd, we elevated process documentation to the next level. Fehlende Blickwinkel und unscharfe Aufnahmen gehören der Vergangenheit an – mehrere hochauflösende Kameras, teils stationär, teils mobil, sorgen dafür, dass Sie Ihren Versuch auch nachträglich aus jedem Blickwinkel betrachten können.
Thanks to excellent microphones that record the entire process, every spoken word remains comprehensible and interpretable. A monitor displays all recorded viewing angles during the procedure. Device data is collected, and observations and special events are recorded immediately.
Phase 1 begins by informing yourself in advance about the prevailing conditions and claims. We determine your requirements for process documentation and adapt our offer for you accordingly.
Phase 2 is dedicated to test preperation. We will set up the operating room exactly according to your wishes and needs. Here, you can see how phase 2 looks like with an animal model:
Phase 3 - the implementation. With the help of the latest documentation technology, you can record every aspect of your experiment. Here, you can see what the setup for an experiment with an animal model might look like:
In Phase 4, at the end of the pre-clinical process chain: the evaluation. All sequences of the experiment are retrievable at any given time.
We do not only provide you with space and technology, but also with our expertise - we're always available to offer additional perspective during the review process.
Our promise
We are at your disposal 24/7 for professional testing and evaluation of medical devices in a preclinical environment. The door to protected dialogue is open to you - from information gathering through planning and implementation to evaluation. We know many of your challenges because we have met them countless times. Scale with us the necessary services on the way to mutual success. SMART.avd - for a faster path to successful preclinical testing.