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ISO 13465
  • want to expand your markets
  • need to be ISO certified
  • have a lot of external checks and audits
  • are a shareholder
    consultant or auditor
The CE mark is a mark of conformity that a manufacturer affixes to a product so that it can be sold in Europe.
these are several management systems (two or more) combined into a single structure that function as onе
Integrated management systems
ISO 13465
The ISO 13485 standard provides requirements for companies and organizations that produce medical devices.
ISO 27001
The standard contains requirements in the field of IT security for the development and maintenance of ISMS
ISO 37001
ISO 37001 is designed to help organizations develop, implement, maintain and improve an anti-bribery management system.
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EU and Switzerland
New Medical Devices
(2017/745/EU) (MDR)
EU Regulation 2017/745, also known as the Medical Device Regulation (MDR), is a European Union regulation governing the approval of medical devices in the EU. EU Regulation 2017/745 covers all medical devices (except devices for in vitro diagnostics and products using gene, cell and tissue technologies), including implantable devices. The regulation replaces EU Directives 93/42/EC and 90/385/EC and came into force in 2017 and by May 26, 2021, all products on the European market must comply with the requirements set out in it. From this point on, EU Directives 93/42 and 90/385 will cease to have any effect. New products introduced to the market for the first time must immediately comply with the requirements of EU Regulation 2017/745.