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Standard [CURRENT] 2021
Medical devices - Information to be supplied by the manufacturer
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
Technical rule [CURRENT] 2021
End-to-end microbiological quality and sterility assurance
from 221.80 EUR VAT included
from 207.29 EUR VAT excluded
Technical rule [CURRENT] 2020
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Medical devices - Guidance on the application of ISO 14971
Medical devices - Post-market surveillance for manufacturers
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
Risk management guidance for combination products
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Standard [CURRENT] 2020
Clinical investigation of medical devices for human subjects - Good clinical practice
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
from 599.20 EUR VAT included
from 560.00 EUR VAT excluded
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
from 524.20 EUR VAT included
from 489.91 EUR VAT excluded
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