REGULATORY AFFAIRS

Medical devices

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Medical devices

We have expertise for medical devices and in vitro diagnostic medical devices (IVDs). Examples of medical devices are sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. IVDs are used to perform tests on samples, and examples include HIV blood tests, COVID-19 tests, pregnancy tests and blood sugar monitoring systems for diabetics.

We will guide you through

  • New Regulations (EU) 2017/745 and 2017/746
  • ISO 13485
  • Implementation of harmonized standards
  • New UDI system
  • Requirements for clinical trials for medical devices
  • Borderline products
  • Reporting to Eudamed
  • Classification rules
  • Requirements for technical documentation and preparation
  • Post-market surveillance and vigilance system
  • Risk management
  • Obtaining CE certificates
  • Provide you with a person responsible for regulatory compliance (PRRC).
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