Many manufacturers face a major challenge in validating reprocessing processes. Unclear requirements, a lack of experience, and the complexity of the processes lead to delays and complaints from authorities and notified bodies. This costs time and money and jeopardizes market approval.
Sleep sound – your reprocessing validation is guaranteed to comply with all legal requirements. No more complaints from authorities and notified bodies.
Avoid expensive repetition of tests by using our proven processes. Benefit from fast turnaround times and predictable costs.
Sit back and let us take care of everything, from planning and laboratory selection to the final documentation. This leaves you free to focus on other tasks.
Be sure that you can continue to sell your medical devices. With our validated reprocessing, you will comply with all market access requirements.
Our support includes:
Criticality Assessment and Classification: We assess the criticality of your medical device and classify it according to Spaulding, which is the basis for all further steps. We also support you in the worst-case selection of representative samples from a product family and provide the necessary justification.
Determining the Reprocessing Methods: We define the optimal procedures and parameters for cleaning, disinfecting, and sterilizing your devices. We research and evaluate all national requirements for reprocessing your medical devices in the target countries so you can be sure you comply.
Creation of Reprocessing Instructions: We help you create precise and standard-compliant reprocessing instructions or optimize your existing documentation.
Laboratory Selection and Monitoring: We select the most suitable laboratory for your requirements and monitor the complete execution of the validation.
Project Management and Communication with Authorities: We manage the entire project and take over communication with authorities and notified bodies.
Contact us to discuss how we can support you with your reprocessing validation.
Phone
+49 7531 94500 20
Contact Form
Do you still need to conduct biocompatibility tests? We would be happy to support you, for example, in developing a strategy and selecting a laboratory.
We help you create a complete and legally compliant biocompatibility file for approval or an upcoming audit.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
