Medical Devices

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Medical Devices

We have expertise for medical devices and in vitro diagnostic medical devices (IVDs). 

Some 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 Eudramed
  • 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).
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER