Director of Medical Device Unit at HungaroTrial CRO
Lead Auditor and Certifier Antal Solyom has worked for one of the most recognized Notified Body’s in Europe (TUV Rheinland) for 14+ years, and previously an additional 3 years at another Notified Body as a Lead auditor, and Head of Mechanical Laboratory. As a MSc in Mechanical Engineering, his background provided the perfect base for gaining experience in a variety of non-active medical devices, adding over the years sterilization, clean room technology, biocompatibility and clinical data review knowledge. Leading the local certification office, and managing the worldwide-active auditor team, he earned a high level of experience in managing certification projects (according to MDD, IVD, PAL, CMDCAS) for a variety of medical devices for small and mid-size medical device manufacturers.
Currently working for the leading CRO in Central Europe (HungaroTrial), where these experiences are well used for projects coming from all over the world.