Mechanical Components

FDA Makes RO Validation Mandatory for Washer-Disinfectors: learn how the new FDA rule impacts 510(k), De Novo filings, RO water validation, and US market compliance.

EU MDR update tightens compliance for H2O2 Plasma Sterilizers, confirming Class IIb status and CER needs from Jan 2027. Learn the CE impact, export risks, and actions companies should take now.

Vacuum autoclave lead times reach 22 weeks as 316L stainless steel shortages disrupt Class B and Class S models. See what buyers, distributors, and OEMs should do now.

FDA Tightens Washer-Disinfector Water Validation: learn how the new 1.3 µS/cm requirement affects 510(k) filings, imports, and field corrections before the October 2026 deadline.

EU Tightens QMS Rules for H2O2 Plasma Sterilizers: learn how ISO 13485:2025 and design dossier audits could impact EU market access before the Dec 1, 2026 deadline.

CSSD equipment maintenance guide covering common failures, alarm checks, preventive actions, and repair-vs-replacement decisions to reduce downtime and protect compliance.

FDA Sets Aug 2026 Validation Rule for Washer-Disinfectors: learn how AAMI ST45:2025 and six-month revalidation could impact US registration, OEM coordination, and delivery timelines.

EU MDR Annex XVI now adds clinical evaluation requirements for H2O2 Plasma Sterilizers. Learn how CER, PMCF, CE compliance, and 2027 deadlines may impact EU market access.

FDA Requires Real-Time Postmarket Reporting for H2O2 Plasma Sterilizers: learn how the 2026 FDA rule affects compliance, hospital procurement, exports, and U.S. market access.