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Certification - Cobams srl

Cobams
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PRODUCT AND COMPANY CERTIFICATIONS

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.

ISO    9001:2015   Quality management systems
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.

ISO  13485:2016  Medical devices -- Quality management systems
COBAMS manage all processes under the ISO 13485:2016 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

Cobams srl , Via Cicogna,20
 40068 San Lazzaro di Savena, Bologna  Italy  
cobams@cobams.com  
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P.IVA IT00524830379

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