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).