PRODUCT AND COMPANY CERTIFICATIONS ( Download )
COBAMS has identified and manage all processes to achieve the expected results (conforming products/services and enhanced customer satisfaction) and has provided the necessary resources to support its business activities and monitor the above processes.
COBAMS demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
COBAMS manage all processes under the ISO 13485:2021 providing medical devices including application of system by monitoring, maintaining, and controlling the processes.
Medical Device Directive 93/42/EEC(MDD) lists the Essential Requirements on safety, efficacy and quality performances that a medical device must meet.
COBAMS conducted the crush-tes 10 g test to determine if the maintain systems (restraint systems) and the fixation of the equipment ( transport incubator code 002/002S ) meets the requirements specified under UNI EN 1789 and UNI EN 1865