Medical

Entering to market starts with a strong partnership, and with over decades years of experience, Delfin trade has partnered with manufacturers to provide global medical device testing, certification, verification and quality assurance solutions. We support the needs of medical device manufacturers throughout the lifecycle of their products. These are the neccesary regulatory requirements for the medical equipments;

IEC 60601: Medical Device Product Safety
EMC Testing for Medical Devices
EU Medical Devices Regulation (MDR 2017/745)
In Vitro Diagnostic Directive 98/79/EC
The CB Scheme
EU RoHS Directive Services
Environmental & Regulatory Services -  RoHS, REACH and WEEE
Medical Management Systems Certification & Auditing - From ISO 13485 to MDSAP
Medical Device Materials Testing and Scientific Support Services - (ISO 10993-18), QC testing
Clinical Research Services - GCP and ISO 14155
SPE-3000 -  (MEE) and medical electrical systems (MES)