Vibronics Lab

Vibronics® Lab Private limited is an Accredited laboratory by National Accreditation Board for Testing and Calibration laboratories (NABL), India for testing of orthopedic devices. With our Machines (Instron, USA, DYNA-MESS Prüfsysteme, Germany, Rockwell Hardness test, Mitutoyo, Japan) we offer testing services for traumatology implants, hip prosthesis, spinal implants, customized implants as well as hardness testing of raw materials. We are following all the Quality Management System procedures as per ISO/IEC 17025:2017. We perform test procedure according to ISO and ASTM standards. Apart from the standardized test, we also offer innovative implant test by custom testing procedures adapted to the specific requirements of customers for ensuring a high level of safety in the pre clinical phases. We are India's first Mechanical testing laboratory for medical devices following Make in India initiative by the Government of India. To benefit our customers economically by providing modern and efficient U.S.A, German and Japanese technology machines for Mechanical test facility of orthopedic devices in India. To meet the European Union Requirements regarding safety and performance of orthopedic devices, we demonstrate the compliance with general safety and performance requirements through mechanical testing laid down in Annex I, Chapter II of European Union Medical devices Regulation (EU MDR 2017/745) as well as the performance bench test and design verification of the orthopedic devices according to USFDA, Pre-Market Notification (510k), Pre-Market Approval (PMA) and ISO 13485:2016 we strictly abide by the ISO and ASTM Standards. The testing method for determining the mechanical properties of polymer based implants apart from metallic orthopedic devices like PEEK OPTIMA, PEEK CF, UHMWPE are most important aspects for safety and performance of medical devices offered by us. We are pleased to welcome you as a new customer of Vibronics® Lab Private Limited.