Document is current
Any future updates will be listed below
-
Authors
Sharma, Neha
Oteiza, Jokin Zubizarreta
Seiler, Daniel
Abazi, Sead
Seifert, Lukas B.
Roethlisberger, Michel
Guzman, Raphael
Thieringer, Florian M.
- License Information
-
More Information
Article History
Received: 29 October 2025
Accepted: 15 April 2026
First Online: 21 April 2026
Declarations
:
: This study was conducted per the Declaration of Helsinki and institutional ethical guidelines. POC manufacturing of patient-specific implants was performed under EU MDR 2017/745 Article 5(5) with notification to Swissmedic (Swiss Agency for Therapeutic Products): CH-202306-0005 and CH-202503-004. Written informed consent was obtained from all patients for surgical intervention with POC-manufactured implants and for publication of clinical data and photographs for academic purposes.
: N.S., D.S., and F.M.T. are cofounders and minority shareholders of POC APP AG (Basel, Switzerland). N.S. and D.S. serve as Chief Medical Officer and Chief Technology Officer of POC APP AG, respectively. J.Z.O. is a part-time employee of POC APP AG. The regulatory compliance framework, including the quality management system (QMS) and manufacturing execution system (MES) implemented in this study, was developed and is maintained by POC APP AG. The remaining authors declare no competing interests.
