In Vitro Diagnostics Services- IVD

IVD Development Process

Med-dev engineers collect your needs and product specifications to create design requirements to cover full IVD device development cycle, including verification and validation of pre-market or production equivalent units.

All development phases will be carried out under Design Control environment following our Qualtiy Management System procedures to guarantee maximum safety and quality to accomplish FDA regulations and EU MDR standards.

IVD Performance Evaluation and Guidance to Market

Following latest development and testing methodologies, low risk devices will be ready to market under safety standards.

In EU, for no low risk IVD devices, Med-dev engineers will work together with NoBo (EU Member States Notified bodies) to seamless assess comformity with applying standards:

In Vitro Diagnostic Medical Devices Regulation (IVDR). (EU) 2017/745 Guidance to Market. Regulation (EU) 2017/746

ME equipment IEC 60601

standard iso 13485.
MEDICAL DEVICE SOFTWARE (MDSW) to fulfil the requirements set out in IVDR
EU Medical Device Regulation
ISO 13485 (Quality Management Systems)
ISO 14971 (Risk Management)
IEC 62304 (Software Life Cycle Processes)
IEC 82304 (Health Software)
IEC 62366 (Usability Engineering)
IEC Biocompatibility

IVD Medical device manufacturing

IVDs mass production providing supply chain and technology vigilance during all product life cycle.