ERA Management (ERA Yönetim) is an İstanbul-based service company for medical device manufacturers, offering regulatory consultancy, quality systems and testing. The office is in Maltepe, İstanbul, and its biomechanical test laboratory is in Şekerpınar, Çayırova (Kocaeli). The company states 20 years of experience in medical device regulation.The laboratory tests orthopaedic and dental implants to ISO and ASTM standards: wear tests for hip, knee and shoulder prostheses, static and dynamic loading of plates, screws, nails and spinal implants, and torsion, bending, fatigue, tensile and shear tests. Further services cover biocompatibility, chemical characterisation, coating, validation and microbiological tests.Consultancy covers ISO 13485, EU MDR 2017/745 and IVDR 2017/746 compliance, FDA and SFDA (Saudi Arabia) registration, Class III drug-device combination products, process and clean-room validation, clinical data collection, internal audits and training. The website states a 2025 accreditation certificate issued by IAS.
Biomechanical TestingHip and Knee Prosthesis Wear TestingSpinal Implant TestingOsteosynthesis Product TestingDental Implant TestingCoating TestingBiocompatibility TestingChemical CharacterisationValidation and Microbiological TestingISO 13485 ConsultancyEU MDR and IVDR Compliance ConsultancyFDA and SFDA Registration ConsultancyClinical Data CollectionProcess and Clean Room ValidationInternal Audit and Training
IAS accreditation certificate for the biomechanical test laboratory (2025 update), as stated on the website
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