Medical Devices
SERVICES
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).
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!
BILLEV PHARMA EAST
Do you have a question for us? Contact us and we will be happy to advise you and find the best solution for you together with you!
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Billev farmacija vzhod d.o.o.
Billev Pharma East Ltd.
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2022 BILLEV PHARMA EAST
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Operation title: BILLEV FARMACIJA VZHOD digitalizacija
Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund”. – Read more
Operation title: BILLEV FARMACIJA VZHOD digitalizacija Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund.” – Read more
