ISO 13485 certification protects consumers by ensuring uniformity and quality in medical device manufacturing, enhancing patient outcomes, and reducing risk and recall. “Procuring ISO 13485 ...

“Achieving ISO 13485:2016 certification is a testament to our unwavering commitment to quality and regulatory excellence,” said Dr. Joseph Nathan, ForSight Robotics’ co-founder, president ...

By achieving ISO 13485 certification, Stratasys Direct is formally recognized for the safety, precision, and reliability of its 3D printed components. This certification addresses critical regulatory ...

ISO Certification highlights commitment to quality for continuous blood glucose monitorRUTHERFORD, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the ...

ORCHARD PARK, N.Y. – Polymer Medical has achieved ISO 13485:2016 certification from NSF-ISR, an NSF company, distinguishing its quality management system, or QMS, for manufacturing medical devices.ISO ...

JC Auditors (JCA) is actively promoting ISO 13485 certification awareness for South African medical-device licenses. Sahpra mandates this certification from April 1, 2025 ...

什么是 iso 13485 标准？ iso 13485 是由国际标准化组织 (iso)发布的独立标准，为医疗器械行业涉及的公司的质量管理体系 (qms) 提供了要求。 该标准基于国际公认的 iso 9001 qms 标准（该标准不特定于任何行业或产品类型），并纳入了与医疗器械流程相关的其他元素。

According to the International Organization for Standardization (ISO), organizations can reap many benefits from implementing the ISO 13485 standard without undergoing the certification process.