https://www.taxtmi.com/news?id=29300 A Quality Management System based on EN ISO 13485:2016 + A11:2021 materially supports compliance with the EU Medical Device Regulation by aligning design, manufacturing, and post-market processes with MDR expectations. Key functions include integrated risk management, clinical evaluation and post-market surveillance, traceability and UDI documentation, supplier control, audit readiness, usability validation, and a CAPA-driven continuous improvement cycle. Embedding these elements reduces technical documentation deficiencies, mitigates certification rejection risk, and aids conformity assessments under the MDR. en-us Wed, 01 Jan 2025 17:01:03 +0530 Wed, 01 Jan 2025 17:01:03 +0530 TaxTMI RSS Generator https://www.taxtmi.com/news?id=29300 A Quality Management System based on EN ISO 13485:2016 + A11:2021 materially supports compliance with the EU Medical Device Regulation by aligning design, manufacturing, and post-market processes with MDR expectations. Key functions include integrated risk management, clinical evaluation and post-market surveillance, traceability and UDI documentation, supplier control, audit readiness, usability validation, and a CAPA-driven continuous improvement cycle. Embedding these elements reduces technical documentation deficiencies, mitigates certification rejection risk, and aids conformity assessments under the MDR. News - Wed, 01 Jan 2025 17:01:03 +0530 https://www.taxtmi.com/news?id=29300