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View Full Version : ISO 13485 - Medical Devices


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  1. Control Over Outsourced Processes - Share some experiences and methods
  2. When Validation Needed? We are changing to new process equipments
  3. Official Government Regulatory Body Vigilance Contacts to use for China and for India
  4. Which ISO Standard is relevant for Refurbished Medical Devices?
  5. Incoming Inspection Sampling Plan ISO 2859-1/ ISO 2859-2
  6. Technical Agreement for Suppliers ??
  7. Safety Standards for Gastro and Urological Catheters
  8. ISO13485 application: can subcomponents or non-medical products be excluded?
  9. Documented Rework Procedure - ISO 13485 Requirements
  10. Raw Material Specifications - Medical Device Company
  11. List of Global Medical Device Nomenclature (GMDN) Codes
  12. IQ, OQ & PQ (Installation, Operation, and Performance Qualifications) on a CMM
  13. Identifying Critical Components for Incoming Inspection?
  14. Advice on Outsourcing all Manufacturing, Warehousing and Distribution Processes
  15. Validation of Commercial off-the-shelf software - Spreadsheets
  16. 21 CFR 820.70 (c) Environmental Control and Pest Control
  17. Continuing Assessment Audit - Recommended for continued registration 13485:2003
  18. Biocompatibilty Testing - National Test Centre (NTC), China
  19. Distributor Requirements - Vigilance and Traceability
  20. Sterilization Dose Audit - Recommended Quantity of Samples/Batches
  21. Recommended for Certification - R&D only (without Manufacturing or Marketing)!
  22. Titles for Quality Functions - Very small business quality department query
  23. Auditing External Suppliers of Finished Devices
  24. Israeli Medical Devices
  25. KPIs (Key Performance Indicators) and Risk Management Process (ISO14971:2007)
  26. List of regulatory steps to obtain market clearance in different countries
  27. GMDN Codes for 'High Frequency Radiosurgical systems'
  28. Start Up Medical Device Company - As a device company what FDA cert do we need?
  29. Is Site Master File necessary for a European Medical Device Manufacturer (class III)?
  30. Medical Device Manufacturer: Incoming Raw Material Inspection
  31. Sterility Assurance Level of Liquids (SAL) - Special Culture Medium
  32. How long must we provide support for medical software
  33. 60601 Symbol Issue - CE Mark Symbol and Size Requirements
  34. Ideas for a Regulatory Careers presentation?
  35. ISO-13485 and ISO-9001 - Medical Device Company - Distributor wants ISO9001
  36. Has ISO 13485: 2003 been Updated?
  37. Review and Implementation of Customer Requirements
  38. Component Specifications - Difficult to get Component Specifications from Customers
  39. STED vs. CE /FDA etc - Seeking advice
  40. Contract Manufacturer - Technical/Device Master File Responsibility
  41. Incorporating Risk Management into CAPA
  42. Management Review output - privileged or audit fodder?
  43. Sample Retention Requirements - Quality Records procedure - ISO13485
  44. Validation Requirements - ISO 13485 / MDD Technical File
  45. Current Medical Device under 9001 Excluded from future ISO 13485
  46. Material Non-conformance per 21 CFR part 820: Subpart I - Medical Devices
  47. MDD Essential Requirements Checklist - Complete?
  48. How to practically organize the 'Vigilance' function?
  49. Surgical Sutures and Absorption - Break strength retention (BSR) properties
  50. Polypropylene Sterilization with Heat Autoclave
  51. Dual Quality Systems? Pharmaceuticals and Medical Devices
  52. Is testing per ISO 10993 - 5 required for resin discoloration ?
  53. Approved Job Descriptions under Revision Control - Required?
  54. Documentation for Returned Contaminated Medical Devices
  55. Releasing documents you are not in compliance with
  56. Cl 7.2.1c Statutory and Regulatory Requirements Related to the Product
  57. Question regarding supplier approvals
  58. Biocompatibility testing & Registration in China
  59. Health Canada Registration - New Class II Medical Device
  60. Need step-by-step ISO 13485 implementation help
  61. Documentation for Health & Safety (OSHA) require ECO's?
  62. Comparison of 21 CFR 820 and ISO 13485
  63. Risk Assessment according to ISO 14971 - Medical Device Software
  64. Sterile Pouch Peel Force of 1 pound/inch width
  65. OEM IVD's and CE requirements
  66. Risk Analysis Requirements - Medical Devices Manufactured prior to 1998
  67. What is a reasonable Bioburden limit?
  68. Is Risk analysis for plastic parts of medical devices required?
  69. Established procedure for Advisory Notices - ISO 13485
  70. Shipping Validations prior to exporting our product
  71. Is spray painting allowed for non-blood contact medical devices?
  72. EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices
  73. EU Vigilance - Internal Forms
  74. Upgrade to NC Database - Root Cause Category Listing
  75. Mark on Medical device label marketed in Canada
  76. CSA Requirements - CMDCAS - ISO 13485 - Medical Xray camera for Canada
  77. GHTF - Study Group 1 (SG1) - Final Documents issued
  78. Who is responsible of Advisory notices
  79. Requirements to market/sell existing medical device in EU, Canada
  80. Gamma Sterility Validation - ISO 11137-2, 4.2 vs. FDA Requirements
  81. 1. Hardware Life Cycle; 2. Requirements tracking; 3. FMEA Risk Analysis
  82. Class 2a Medical Device (Nebulizer) - What is best route to getting CE mark?
  83. Health Canada : Requirement for Inter-dependent Medical Devices
  84. ISO 10993 - Required Testing - Can I follow the literature route?
  85. Can I perform an ISO 13485 audit? I'm a registered RABQSA QMS and AS9100 Auditor
  86. Product Storage Specifications
  87. Iran - Medical Devices Regulations - Homologation
  88. Startup Medical Device Manufacturing Company Guidance
  89. Contract Manufacturing of Medical Device
  90. Ethernet port connections to meet 60601-1 and 60601-1-2
  91. Support for Obsolete Medical Devices
  92. Signature on Management Review Minutes - Quality Records
  93. Lean SCAR Process and Form needed - ISO 13485 and FDA
  94. Global Medical Device Requirements
  95. EtO Sterilization - DIN/EN 550 - ISO 11135
  96. Correct Label Symbol to be used for Steam Sterilisation
  97. QC Testing - Repeat test sample numbers
  98. Starting fresh with ISO 13485:2003 certification
  99. Affordable electronic CAPA system (compliant to FDA 21 CFR Part 11)
  100. Are batteries in a Medical Device, also considered a MD?
  101. Medical device facility validation - Need help
  102. Medical Device Registration requirements for Algeria and Libya
  103. Batch / Lot Numbering - Sterilization
  104. Are Sales allowed Under an expired CE Certificate?
  105. Label placed on medical device by subcontractor based outside USA
  106. How to practically-conduct, post production phase
  107. Question: outsource medical device electric safety test to OEM supplier
  108. What Constitutes "Manufacturers Claims" about a product?
  109. Anyone having ppt file on Advisory Notices ?
  110. DHR and components under deviation - Medical Devices
  111. Changes to Component Specification & Manufacturing Site
  112. Pre-packaged quality systems - Class IIa Medical Device
  113. Do nonconformances always result in corrective action
  114. Custom prototype checklist for Europe and FDA
  115. Technical File vs. Design Dossier? Class II and Class III Medical Devices
  116. Product Release vs. Pyrogen Test on each Lot - Medical devices
  117. ISO 14971: Perceived or alleged risk?
  118. Validation of bone screw manufacturing process
  119. Code review as part of software validation
  120. Upcoming FDA ISO 13485 audit guidance (draft version)
  121. Bioburden tests duration and Monitoring of gloves
  122. Essential Requirements - Example of the essential requirements filled in
  123. Soldering Standard - What is the soldering standard used for medical devices?
  124. User Interface Label language Requirements
  125. Classification of Bio-diagnostic Products as per EU Directives
  126. Internal Audit Check List for Passive Medical Equipment
  127. Administrative personnel training - ISO 13485 and FDA QSR requirements
  128. Class 8 100,00 Cleanroom - Airborne Microbial Count
  129. Process Approach - Implementing ISO 13485
  130. New intended use - Validation of a class IIb implantable (non-active)
  131. What certifications needed when doing Plastic Parts Manufacturing?
  132. ISO 13485:2000, 2003 ...and all certificates for medical devices
  133. Product vs. Process Change Control
  134. Cleaning standards for Medical Devices - Implants - Cleaning Validation
  135. Identifying Inspection Level for Critical Components - Medical Devices
  136. When is the revised standard ISO 13485 going to be released?
  137. Medical Electrical Equipment / System Peripherals - IEC 60601-1-3
  138. Risk Management Plan for Medical Device - ISO 14971
  139. Coming up with initial policies sufficient to get everyone headed on the right track
  140. CAP for Medical Device Class Is product - Slightly confused - ISO 13485
  141. Organization Structure - Small Company, alotta business
  142. Does anyone have a Cleanroom audit checklist?
  143. Outsourced Manufacturing - Do we or our manufacturer has to perform the validation?
  144. Manufacturing date on serial number plate?
  145. Successful Validation = Reduced Inspection? No Inspection??
  146. Relevant Packaging Standards for Medical Device Package testing
  147. Contradictions in the reporting timelines of IVD Directive and MEDDEV 2.12-1 Rev 5
  148. Training & Competency - ISO 13485 - Question
  149. Applying AQL when 0 defects are acceptable
  150. ISO Occurrence Form CG00010196
  151. Oxygen concentrator hazards
  152. ISO 13485 for medical device company in US
  153. Standards used for Medical Device MDD Technical Files
  154. IEC 60601-2-6, Microwave Therapy Equipment
  155. Cleanroom Gowning Disposable Lab Coats - Class 8 Cleanroom
  156. CE-marked products transport to Non EU countries...
  157. Which supplies/suppliers need to be listed in DMR?
  158. GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003
  159. BS EN980 and Latex symbol
  160. Who should be involved in Management Review?
  161. Medical Device Choke Hazard standard or guidance
  162. Non-medical device is in the ISO 13485 audit scope?
  163. New ERP system Validation
  164. Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfaction
  165. Integrated CAPA database for internal audit and nonconforming material
  166. Medical Device Suppliers Becoming Certified to ISO 13485
  167. Package validation on a different product in an already validated package?
  168. Installation Requirements for Bench Top Device
  169. ISO 13485 vs. GMP - Is there a difference between ISO 13485 and GMP?
  170. How to set quality objectives of R&D outsourcing - Examples please
  171. Software for Medical Devices and ISO 13485
  172. Measure "TYP" dimensions on a first article inspection (FAI) report?
  173. Dealing with Outsourced Processes in a DMR
  174. Cost to obtain ISO 13485 Certification/Registration from Start-up
  175. Any experience with Clinivation??
  176. Should we perform Equipment final calibration-Operations closing
  177. Tips/Documentation samples required for X-ray Film Processor Installation needed.
  178. What is Risk Analysis certificate? Class III Medical Sutures
  179. Please help me to convert from ISO9001 to ISO13485
  180. U.S. – China Joint Commission on Commerce and Trade (JCCT) - Fact Sheet
  181. Risk management procedure is Mandatory?? (ISO 13485)
  182. Oxygen gauge on Nitrogen supply
  183. Periodic Review of Process and Equipment Validation
  184. Risk Management and Manufacturing of Prototype and Test Devices
  185. Customer Supplied Product & Certifications - Drop Ship - FDA and ISO 13485
  186. Hydrophilic Coating of catheter shafts failing durability
  187. Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements
  188. CE Marking Basics - Laser - I am new to Regulatory
  189. Updated MDD "Single Use" definition
  190. ISO 13485 Risk Management for Contract Manufacturer
  191. Minimum label content requirements for each level of packaging (inner, outer, etc)
  192. Is there a requirement for country of origin on packaging of class 2a medical device?
  193. Version of Medical device safety standard - IEC 60601
  194. Medical Device and Importation Requirements for Tradeshows in EU
  195. Product Release - Final acceptance activities and acceptance records
  196. Medical Devices Jobs - Abbott is currently hiring
  197. In-Process Non-Conformance Report Contents
  198. Packaging validation / qualification report for medical devices - Example wanted
  199. Approved Supplier List ISO 13485
  200. Acoustic Noise of a Medical Equipment
  201. Medical Device Exporters into Hong Kong - Workshop No. 27 (conducted in Cantonese)
  202. MDD Classification - Marketer Has Misclassified A Product?
  203. Changes to QRI (Quick Reference Instruction)? What I can or cannot change
  204. Gulf Cooperation Council (GCC) Common Market for Medical Devices?
  205. Turkish factory under US umbrella - Small medical device manufacturer
  206. Does EN 60601-1 include 60601-1-2 from a contract point of view
  207. BioHazard Cleaning of Returned Devices - Small Medical Device company - Need Ideas
  208. Ownership of ISO 13485:2003 company changing - Anyone to update?
  209. Repairs vs. Scrapping for Parts and Serial Numbers
  210. IEC 62304 compliance status - Is it mandatory for 510(k) submittal?
  211. Asian Harmonization Working Party to hold meeting on Nov 5, 6 in Delhi
  212. Effectiveness of Supplier Corrective Actions
  213. Is a Test or Prototype Implant a Medical Device per ISO 13485 definition?
  214. The air kerma measuring device - Does anyone know anything about it?
  215. JMDN (Japanese Medical Device Nomenclature) codes list needed
  216. ISO 13485 IAF Medical Device Conformity Assessment System IAF-MDCAS
  217. ETO Sterilization - Process monitoring and out-inspection
  218. Suitable Sterilization Cycle to achieve Sterility Assurance Level of <10-6
  219. External Document Control Procedure advice wanted
  220. Keep current ISO 13485 registrar AND add new for CMDCAS
  221. Tough Decision - Not a medical device anywhere except US and Canada
  222. Clean Room - Standards or some type of Clean Room Validation - ISO 13485
  223. Filing of Registration Documents in an organised or consistent way
  224. X-ray's light testing - What is the standard to test the X-ray light brightness?
  225. New Directive Outlined for Medical Devices by ASEAN
  226. USB Port Isolation as per IEC60601-1 - Medical Device
  227. Medical device with NON medical PC - USB galvanic insulation
  228. GMP Stores qualification/validation plan or protocol - New Store requirements
  229. ISO 13485 implementation - Other required standards and guides
  230. FDA Regulation Training Materials
  231. Supplier Quality vs. Supplied Material Quality
  232. I will be an ISO 13485 Auditor soon - Your suggestions are appreciated
  233. Registration/Homologation Colombia & Cuba - Class I and IIa medical devices
  234. CLIA vs. QSR Audit Differences - and - Audit templates for CLIA audits
  235. Device Master Record requirements - wrong approach?
  236. Could We use electronic signatures rather than manual sign offs?
  237. Are artificial teeth medical devices? If so, which class do they belong to?
  238. Medical device registration process in Brazil - Anvisa
  239. Guidelines that specify the frequency of ETO Sterilizer Re-Validation
  240. Italian Device Classification - CND
  241. Utility - Electrical operation qualification protocol for validation
  242. Biocompatibility testing centre in Montreal QC ?
  243. Best Risk Analysis Approach (ISO 14971) - Class IIa medical devices
  244. Protocol to validate the use of Electronic Records like DHRs, NCMRs, Validations
  245. Appropriate FMECA handling of cascading failures?
  246. Risk of fire in an Oxygen rich environment - Fire Prevention - IEC 60601-1
  247. The key differences between EN 46001 and ISO 13485
  248. ISO 13485 and network security protection - Medical device manufacturer
  249. CMDCAS (Canadian Medical Devices Conformity Assessment System) for drugs
  250. Medical Device Adhesive with USP class VI, suited for oral 'use'