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Understanding ISO 13485: A Brief, Yet Comprehensive, Overview …
WEBDec 15, 2014 · The primary international version is iso 13485:2003. The variant EN iso 13485:2012 is the latest European harmonized version of iso 13485; it replaces the prior harmonized version, EN iso 13485:2003, which is now considered to be obsolete. EN iso 13485:2012 is applicable only to manufacturers placing devices on the market in Europe.
Psma.comMembers in the news - PSMA
WEBThis is the first time a standard switching power supply manufacturer in Japan has received iso 13485 certification and brings the group total to five locations. The scope of this latest registration covers the Design/Development, Manufacturing and Servicing Activities (Analysis, Repair and Overhaul for Field Returns) of Components (Switching Power …
Psma.comPSMA Update
WEBQuality Certifications - ISO 9001:2015/iso 13485:2016/ISO 14001:2015/IATF 16949:2016/ISO 45001:2018/ITAR & FDA Core Competencies - 25+ years of experience/full service provide specializing in high mix, low to mid volume programs/value engineering services/supply chain services
Psma.comSafety & Compliance Forum | PSMA
WEBThese articles discuss compliance requirements related to safety, electromagnetic compliance (EMC), energy efficiency, and other areas affecting power supply approvals regionally and globally for diverse applications and markets. The articles discuss compliance issues from the design stage through pre-compliance and final compliance …
Psma.comUsing EN 50581 to manage compliance to the upcoming RoHS
WEBUnderstanding iso 13485: A Brief, Yet Comprehensive, Overview; Using EN 50581 to manage compliance to the upcoming RoHS phthalate substance restrictions Slides; Video recording; What should you know about RoHS 3? Patrick Le Fevre, Powerbox
Psma.comHome | PSMA
WEBDec 18, 2006 · iso 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes ISO
Psma.comSafety & Compliance Forum | PSMA
WEBMay 22, 2024 · Skip to main content
Psma.comSafety & Compliance Forum - PSMA
WEBBS EN ISO 11137-3: 2017 will help with meeting the dosimetric requirements of radiation sterilization in BS EN ISO 11137-1 and -2, as the revised standard also introduces and formally defines the concepts of ‘direct’ and ‘indirect’ measurement of dose. BS EN ISO 11137-3:2017 will be available on the BSI shop shortly. Find out more
Psma.comPSMA Update
WEBTheir Quality Management System is ISO9001:2008 and is now also iso 13485:2003 (Medical) registered, plus the vast majority of their suppliers are ISO registered companies as well. Fedco takes particular pride in absolute customer service excellence and are consistently rated among the best suppliers by their customers and vendors alike.
Psma.comIsolation in Industrial Motor Drives - PSMA
WEBISO and V SURGE requirements from System Voltage. –For reinforced use 2x V ISO, and next level of V SURGE. •Step 4: Determine Clearance based on V ISO /V SURGE levels determined in step 3. –For reinforced use 1.6x the V ISO, and next level of V SURGE. –Scaling factor required for altitudes > 2000m
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