ISO 10993 TESTING SERVICES Biological Evaluation Plan (BEP) We begin by developing a Biological Evaluation Plan (BEP), which reviews the device and its materials, identifies potential biological risks, and suggests appropriate evaluations or testing strategies....
IEC 60601 Testing Services Foundational Standard IEC 60601-1 Compliance The IEC 60601-1 standard is the cornerstone of the series, setting the general requirements for basic safety and essential performance. We provide thorough testing to ensure your device meets...
KEY ASPECTS OF EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES Representation for Non-EU Manufacturers We act as your official representative within the European Union, a mandatory requirement for non-EU manufacturers under the EU Medical Device Regulation (MDR)....
OUR EXPERTISE Technical Documentation We assist in compiling, reviewing, and updating technical files for medical devices, medical device software, and in vitro diagnostic devices. Quality Management Systems Our services include building, auditing, and updating...
KEY ASPECTS OF FDA APPROVAL PROCESS SERVICES 510(k) Clearance (Premarket Notification) The 510(k) process involves submitting a device to the FDA to determine if it is substantially equivalent to a legally marketed device that is not subject to Premarket Approval...
