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How can proof be provided and documented in an audit-proof manner that a process, procedure or method actually fulfills the previously defined specifications?
Validations are essential in medical technology. The certificate course deals with the different approaches and methods along the typical production chain of medical devices and deepens the know-how based on practical concepts. This involves both what needs to be validated and the question of how the data is collected, analyzed and evaluated in a statistically reliable manner - in order to be able to implement the validation effectively and pragmatically in your own company. From the ground up: Terms such as "measurement uncertainty" and "repeatability" are explained, as are the individual stages of validation - a strict practical orientation serves as an aid to concrete implementation.
target group
Employees who carry out or will carry out validations in the company themselves, or who check validations or accept their approval.
Topic overview & dates
05/15/2024 Validation of processes in the medical device industry (hybrid)
06/04/2024 Verification of medical devices: The suitability of test equipment, test processes and test methods (hybrid)
06/13/2024 Design verification and validation (hybrid)
06/25/2024 Computer system validation (hybrid)
07/03/2024 Statistical methods in the validation of processes (online)
07/17/2024 Practical day at the machine (presence)
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After passing the exam, the participants receive a certificate issued by MedicalMountains GmbH.
Funding Opportunity
ESF funding is possible. More information can be found here .
early booking discount
If you register up to 4 weeks before the start of the course, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
