Questmed for Medical Device CertificationQuestmed GmbH offers biomechanical laboratory services to medical devices manufacturer concerned with the fields of joint replacement, osteosynthesis, dental implants and cardiac devices. We are specialized in static and dynamic mechanical testing of implants and we possess experience for decades. We are adept in almost every tests regarding fatigue and wear of implants, their analyses and documentation.
Questmed is accredited by the DAkkS Germany according to DIN EN ISO/IEC 17025:2018 and 93/42/EEC and recognized by the ZLG Germany according to 93/42/EEC, EN ISO 17025 and § 15 (5) medical devices act for physical and physical-chemical testing of non-active implants.
The Questmed GmbH was founded in 2008 in Greater Berlin. Since 2018 we are also established in Jena.
Christian Abicht (Dr.rer.med. Dipl.-Ing.) is the CEO of Questmed GmbH. He was general manager and quality manager of the Questmed GmbH for many years. He studied electrical engineering, received his PhD in Anatomy.
Before his Questmed time he worked as product development manager for medical devices and performed the Medical Device Certification according ISO 13485, 93/42/EEC for CE marking and FDA 510k.
This experience helps to understand and merge the manufacturer and the notified body for Medical Device Certification process and requirements.
Questmed is also active member and expert of DIN, ISO and FDA working groups for medical devices.