TY  - CHAP
A1  - Carl, Ann-Kathrin
A1  - Kirillov, Maxim
A1  - Hochmann, David
A1  - Quadrat, Eric
T1  - Towards credible computational models: Application of a risk-based framework for establishing credibility
T2  - Transactions on Additive Manufacturing Meets Medicine
N2  - The use of computational modeling and simulation (CMS) as a tool for gaining insight into the technical performance and safety of medical devices has emerged continuously over the past years. However, to rely on information and decisions derived from model predictions, it is essential to establish model credibility for the specific context of use. Limited regulatory requirements and lack of consensus on the level of verification and validation activities required result in rare use of CMS as a source of evidence in the medical device approval process. The American Society of Mechanical Engineers (ASME) developed a risk-informed framework to establish appropriate credibility requirements of a computational model: the ASME V&V 40?2018 standard. This paper aims to outline the concepts of this standard and to demonstrate its application using an example from the orthotics field. The necessary steps to establish model credibility for a custom?made 3D printed wrist hand orthosis (WHO) are presented. It is shown that the credibility requirements of each verification and validation activity depend on model risk by applying two different contexts of use to the same computational model.
KW  - computational modeling and simulation
KW  - CMS
KW  - validation
KW  - V&V 40
KW  - model credibility
Y1  - 2023
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:hbz:836-opus-173821
SN  - 2699-1977
ER  - 
TY  - CHAP
A1  - Wittrock, Ulrich
A1  - Welp, Petra
T1  - Adaptive laser resonator control with deformable MOEMS mirrors
T2  - MEMS/MOEMS Components and Their Applications III, Proc. SPIE
N2  - Adaptive laser resonators with deformable MOEMS mirrors under closed-loop control are discussed and experimental results are presented. The requirements for deformable mirrors and for closed-loop control systems of these mirrors are analyzed. Several deformable mirrors have been characterized and the results are presented. Currently available membrane mirrors deform under laser load and need further development before they can be used for aberration correction of solid state lasers above some tens of Watts. Nevertheless, the results are encouraging and the requirements are within reach of currently available technology. Finally, we demonstrate an Nd.YVO4-laser with a closed-loop adaptive resonator and more than 6 W of output power. The closed-loop system was able to compensate artificially introduced aberrations from a phase plate.
Y1  - 2006
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:hbz:836-opus-6537
VL  - 6113
SP  - 61130C
PB  - SPIE
ER  -