ISO 13485 Insights for IT Business

Service Description

One of the requirements of the ISO 13485 standard is the identification and traceability of the entire product life cycle, which in our case is a medical device. Therefore, if your company offers software for companies at the intersection of IT, medicine, diagnostics, rehabilitation, preventive medicine or patient data processing, you should likely consider ensuring that employees have the necessary competencies and implementing the ISO 13485 system. If you are still in the stage of assessing the relevance of these requirements and looking for new opportunities to enter the medical device market, XportKat can provide you with recommendations on how to prepare for this process as painlessly as possible. XportKat provides medical device manufacturers with a wide range of solutions for successful penetration into the EU market and sales in both the EU and markets of countries that default to CE marking. For more information on our other products, see here: 📌 As part of the global expertise network, XportKat works with a large number of partners in different countries around the world to provide long-term support to medical device manufacturers. For more information on some of our partners, please see here: 📌 To sign up for a free short consultation on preparing a clinical report as part of the preparation process, please leave your application here. 📌 Thank you for your interest, trust, and decision. Request a callback.