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Technical rule [CURRENT] 2019
Medical device safety assurance case guidance
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Principles for medical device security - Postmarket risk management for device manufacturers
Standard [CURRENT] 2019
Medical equipment management - Vocabulary used in medical equipment programs
from 156.80 EUR VAT included
from 146.54 EUR VAT excluded
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
Non-invasive sphygmomanometers - Clinical investigation of intermittent automated measurement type
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
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