UDI Codes – the key to safety and easier identification of medical devices
As experts in R&D and regulatory requirements for substance-based medical devices, we present you with a Dose of Practical Knowledge to help you better understand legal aspects and industry standards. Leverage our expertise to successfully launch and market your medical devices! One of the key changes introduced by MDR 2017/745 for European medical device manufacturers is the requirement to assign unique UDI codes to their products. UDI labeling applies only to devices...
2024 SUMMARY IN GOFARM
With new energy and optimism we start 2025! We are exposed to risk and risk of an event and to further development as a substance expert of devices.We received a response - from our client, Partner, Supplier - for trust and control in 2024, which were approved by our goals and intention.See in a nutshell what infection in our company! 1. Regulatory Challenges and Successes In 2024, Gofarm focused on adapting its...
We are starting audits to certify Gofarm medical devices!
This important moment has finally arrived! We are pleased to announce that, as one of the first manufacturers of substance-based medical devices in Poland, today we are starting a series of certification audits for the first 13 medical devices from our portfolio for compliance with MDR 2017/745! We are waiting for 4 audits of the notified body PCBC S.A., thanks to which Gofarm products will soon obtain certificates of compliance. The first...