Medical

ITL can provide the quickest worldwide access for your medical electrical products.
ITL offers to manufacturers of Medical Electrical Equipment the fastest and most professional services available in Israel.
ITL is an active member of the key committees and organizations that develop standards for medical products.

Medical Devices Services offered by ITL

• Safety and EMC:  Design Consulting (which standards apply, implementation of all applicable standards, etc.), full testing, check-up pre-testing (for Helsinki Committee) according to the following standards:
  • IEC/EN/UL 60601-1, CSA 22.2 No. 601.1, IEC/EN 60601-2-x, IEC/EN 60601-1-2;
  • Risk Management and Usability Engineering File elaboration and evaluation according to the ISO 14971 standard and IEC 60601-1-6 standards.
  • Guidance design support for Home Care Medical Electrical Equipment;
  • Experienced consultation and guidance to small companies in licensing or selling products they have developed to large organizations. Our expertise allows us to act as impartial experts in device safety during litigation;
  • Monitor and report on the content of selected standards, revisions and amendments for impacts to specific products and processes;
  • Development of standards compliance strategies for new products (tactical) or for the entire organization (strategic);
  • Training in the Application of Medical Device and Process Standards (IEC, ISO, CEN, CENELEC, AAMI, ASTM and on the evolution of regulations and Global Harmonization;
• For European Union, ITL provides a complete turnkey package, working with leading European  Notified Bodies:
  • Complete assistance in obtaining CE Marking according to the Medical Devices Directive 93/42/EEC; Annexes II, III, IV, V. & VI.
  • Project Management for CE Mark MDD and Technical File Management;
  • Quality System Certification according to ISO 13485;
• For North and South America, ITL provides a complete turnkey package including:
  • NRTL (UL or TUV or CSA or ETL or MET, or other – per client request) Mark according to the UL 60601-1 standard;
  • Project Management for FDA 510 (k) submission and Technical Documentation Management;
  • Quality System implementation according to the ISO 13485 and 21CFR820 (and other relevant CFR  documents).
• For Far East and Australia, ITL provides a complete turnkey package including:
  • Testing for particular requirements from Japan
  • Complete assistance in obtaining registration in China, South Korea, Japan, Australia, New Zealand, etc.

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