Česky | English | Deutsch | Polski | По-русски | 中文 | 한국어 | Hrvatski | Türkie | ไทย |
ITC
Medical Devices - summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation

The European Associtiation for Medical devices of Notified Bodies (TEAM NB) on web site, in the section "Latest News", published on December 14, 2018 a document called "White Paper: One Year of Application" summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation regarding to Medical Devices Regulation (MDR) and In-Vitro Medical Devices Regulation (IVDR).


Contacting the Certification Division's executives while moving to new locations

Dear clients, In cases if you are not able to reach the specific employee from Certification Division, please contact head of certification activity on mobile phone. CONTACTS AVAILABLE HERE


Moving the Certification Division's workplaces to a new company space

Dear Clients, during the month of April 2019, certification division's workplaces will move into the new company space of ITC - Building 113, Svit area (address: Trida Tomase Bati 5264, entrance from Malotova street).

If you are going to plan a personal meeting with employees from certification division, confirm the meeting place with the specific employee.


PF 2019

Dear Clients, we would like to thank you for your confidence in cooperation with our company during the past year.

We would like to use this opportunity to wish you good health, happiness and success in 2019, both personally and professionally.


new gas chromatograph in laboratory of analytical chemistry

In August 2018 our laboratory of analytical chemistry purchased a brand new gas chromatograph, mass spectrometer Shimadzu GCMS-QP2020, equipped by a thermal desorption unit TD-30, which is used for analysis of emissions of organic substances.

 

The spectrometer has a superior sensitivity for organic substances in orders of micro-grams per kg of sample. The system is mainly used for analysis of volatile organic substances (VOC) and condensable substances (FOG) according to the requirements of automotive standard VDA 278, but also for emission measurement of polymer samples to investigate additive system, smell, NIAS (not-intentionally added substances in plastics) etc.

 

Contact for such types of analysis: Franky Puype, phone: +420 577 601 703, e-mail: fpuype@itczlin.cz


In-vitro diagnostic medical devices

Products certification, CE » Conformity assessment (CE)

In-vitro diagnostic medical devices (IVDs) are used for measuring the amounts of specific substances in the blood (or urine or other body fluids), for the measurement of the physical properties of the sample, for the microscopic evaluation of cells, for growing microbiological cultures and for similar purposes. The IVD must meet the relevant requirements of Council Directive 98/79/EC. The IVD must undergo the appropriate method of compliance assessment, on the basis of which the EC declaration of conformity is issued and for which each product carries the CE marking. Institute for testing and certification is a member of TEAM-NB and is a  signature of an ethics code (Code of Conduct).

 

Preliminary questionaire   Manual for clients
Application for conformity assessment   Searching the database of certificates
GFA (general framework agreement)   News
Legislation and  other documents for conformity assessment      

SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF MEDICAL DEVICES

  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the:
    • Council Directive 98/79/EC, laying down the technical requirements for in vitro diagnostic medical devices
    • Council Directive 2006/95/EC, laying down the technical requirements for low voltage electrical equipment
    • Council Directive 2004/108/EC, laying down the technical requirements for products in terms of their electromagnetic compatibility
  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • Granting licenses for voluntary certification mark “ITC certified quality
    ITC grants a license for the use of the quality mark, which is granted to the products where high standard of safety and quality parameters has been proved by certification and where meeting the prerequisites of the producer for continuous quality compliance has been proved through inspection visits.
  • Standardization services – analyses of technical information
  • Certification of management systems (ISO 13485, ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspection – statistical inspections, inspection certificates

PRODUCTS ASSESSED IN ITC ACCORDING TO the Council Directive 98/79/EC

Institute for Testing and Certification, Inc. is notified as the Notified Body No. 1023 for conformity assessment of all in vitro diagnostic medical devices.

CONTACTS

Person Phone fax e-mail
Tomas Zavisek, Ing.,
Head of department medical devices certification
+420 577 601 254 +420 577 104 855 tzavisekPostaitczlin.cz


Post address:
Institute for testing and certification, a.s.
Department of medical devices certification
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

The person responsible for accuracy of data: Ing. Tomas Zavisek

Updated: 4.3.2019
 
Webdesign studio
We use cookies that make this site work. By using our services you agree to use them. More about cookies I AGREE