Qualification and Classification analysis
If you’re unsure whether the Medical Device Regulation (MDR) applies to your product, we are here to provide you with the answers you seek. Our vast experience in handling a wide range of innovative solutions enables us to offer you a thorough argumentation that is easily comprehensible to external readers and can be seamlessly incorporated into your technical file.
MDR & ISO 13485 implementation
If your organization has existing processes in place, integrating MDR requirements into your daily operations should be a seamless transition. Our objective is to align MDR requirements with your current management system or build one ourselves, ensuring a harmonious integration. As MDR impacts various organizational processes, our approach aims to make it accessible and workable for everyone involved.
Internal audits
Are you seeking an external perspective to conduct an audit of your organization prior to the arrival of the external auditor? Look no further. With our extensive experience in auditing software companies, we can provide you with a thorough assessment, identifying any non-conformities and highlighting potential areas for improvement. Our expertise allows us to bring a fresh set of eyes to your operations, offering valuable insights that can help strengthen your processes and enhance overall performance.