April 2026

ISO 13485:2016 vs. China Medical Device GMP Comparison | Technical Reference Comparison between ISO 13485:2016 and China New Medical Device GMP A detailed technical mapping based on the latest NMPA Inspection Principles for international manufacturers. Contact for Gap Analysis Support and determine the design and development of each departmentActivities andinterface,jelasTanggung jawab dan pembagian kerja. When […]

ISO 10993-7:2026 Guide | Determination of EO and ECH Residuals in Medical Devices Compliance Reference: ISO 10993-7:2026 Biological Evaluation of Medical Devices 4.4 Penentuan Etilen Oksida (EO) and ECH Residuals Expert summary and technical interpretation of the 2026 updated protocols for sterilization residual analysis. Optimize Your Aeration Cycle Technical Inquiry 4.4.1 General Procedure The

Etilen Oksida (EO) Exhaust Gas Treatment Specification | BOCON Medical Standards Industry Standard: EO Sterilization Exhaust Management Medical Device Sterilization — Specification for Ethylene Oxide Sterilization Exhaust Gas Treatment Technical compliance guidelines for safe collection, transport, and purification of EO emissions in accordance with global regulatory frameworks. Request Compliance Consultation Technical Data Sheet Normative References