Medical Device Assessment and Certification

The Medical Device Assessment and Certification team at the National Standards Authority of Ireland (NSAI) is responsible for evaluating and certifying medical devices to ensure they meet the necessary standards and regulatory requirements for safety, quality, and performance. This team conducts thorough assessments, audits, and inspections of medical devices, ensuring compliance with international regulations and facilitating market access. They work closely with manufacturers to provide guidance on standardisation and regulatory processes, contributing to consumer confidence and the global recognition of medical products.