Are you tired of juggling complex quality requirements while trying to focus on innovation? 🤔
Worry no more! Our dedicated team of experts, including our independent Quality Department, is here to provide comprehensive support tailored to your needs. Whether you’re a local client in Poland or an international partner, we deliver the same level of excellence and offer the following solutions:
📑 Complete technical documentation for your medical devices.
✅ Guaranteed compliant labeling for your products.
🔖 Declaration of conformity for each medical device.
📋 Streamlined registration of your medical devices with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (later integrated into the EUDAMED database).
🔢 Accurate UDI coding in line with industry standards.
🏢 Assistance in obtaining the Free Sales Certificate.
🔒 Ongoing post-market surveillance (PMS) to ensure product vigilance.
Our commitment to quality knows no bounds! 💪
Feel free to reach out about how we can collaborate or start a partnership: