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Medical Device
is a tool, a machine, a device or another product that is used individually or in a combination with computer program needed for its proper operation. Medical device is assigned by its manufacturer for diagnostic, preventive, monitoring use or for therapeutic use, for alleviation of an illness or for a compensation of an injury/disability, for observation, substitution or modification of an anatomical body part or physiological process, for birth conception regulation, whose main effect was not achieved neither by a pharmacological, immunological means, nor by metabolism, but whose function can be supported by the help of these means. The equipment of a medical device is considered as a medical device as well. The given equipment has to be specifically assigned by its manufacturer to be used in a combination with the medical device.
Competencies
TSÚ Piestany, š.p. is a Notified Body EU with as assigned identification number 1299 , for the directive 93/42/EHS - Medical Devices.
Certification body for products certification is accredited by SNAS for Medical devices, Diagnostic medical device in vitro and Active medical device that can be implanted.
Conformity assessment
Policy of a conformity assessment concerning the medical device – generally:
identification of a product,
description of a product and purpose of its use,
specification of a product character considering the body contact,
specification of a time period when the product is used,
classification of a product in accordance with the Annex no IX, NV,
means of a product conformity assessment,
clinical tests,
aftermarket inspection,
complete technical documentation of a product,
participation of a NP/AP.
Individual policy of conformity assessments:
Medical Devices - Government Decree 582/2008 Journal of Laws:
performance of a projection examination, type examination and examination of every single Medical Devices,
issue of a certificate about a projection examination, type examination and examination of every single Medical Devices,
„system of a production quality“ examination,
„system of a product quality“ appraisal,
performance of an inspection.
Medical Devices Certification
Certification of Medical Devices provides Certification Body for products certification and issued Certificate.
Last update: 12.3.2012 |
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