The Elsmar Cove Forum > ISO (International Organization for Standardization) Standards > ISO and IEC Medical Device Related Standards > ISO 13485 - Medical Devices - Quality Management Systems

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1. The Don Winton Memorial FDA Stuff Archive
2. ISO 13485 ISO 13488 vs. EN 4600 EN 4601 Series
3. FDA has auditing guidelines posted on it's web pages for QSR
4. What MUST be signed and dated? FDA QSR requires signatures for specific sections
5. Classification rules for Canada - Electrosurgical and Cryosurgical Equipment
6. Medical Device Industry Links
7. Systems Requirements Mandated by EN46001 and EN46002
8. Purchasing Procedure - QSR §820.50 and ISO 9001:1994 Clause 4.6
9. Process monitoring - Stationary and portable oxygen units
10. Verification Activities - Clinical Medical device manufacturer
11. Continuous Certification - ISO 9001 Certified EN4600 - Why the 3 year recert audit?
12. ISO 13485:1996 - EN 46001 - Medical devices - Particular requirements - ISO 9001
13. Where can I buy EN46000?
14. Passivation Validation - Is passivation is considered a "special" process by the FDA?
15. FDA QSRs and ISO 9001:2000 - CFR 21 Part 820 and CFR 21 Part 58
16. QSR Purchasing Controls governing evaluation and use of consultants
17. History and Current Status of ISO 13485?
18. Particulate On Final Implantable Devices
19. I would like to know the requirements for USFDA approval
20. Looking at 21 CFR 820.20 which calls out in section (d) for Quality Planning
21. En 550/554 - The European Commission Standards Harmonization
22. Software Validation - CAD-type program that will produce Engineering drawings
23. 21CFR820 vs. ISO 9000:2000 - Cross Reference Matrix Attached
24. Food and Drink in Production Areas - Manufacturer of FDA analytical and diagnostic
25. What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820?
26. cGMPs, Quality Requlations for Drug Manufacturer's & Their Suppliers
27. Quality Regulations for Drug Manufacturers & Their Suppliers
28. Clinical Trials in Europe - What is the "competent authority" in Italy?
29. Notified Bodies - Notifying Customers when Changing Registrars?
30. Pursuing certification to ISO 13485 (actually 13488)
31. Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000
32. Micro Contamination - Emoderivates (producing albumin, etc from human plasma)
33. Where can I buy ISO 13485?
34. ISO 13485 and ISO 17025 Interface - Laboratory vs. Parent Company
35. Anyone know Coca Cola's (Coke) QA system?
36. Finished product visual status - Each box must have a QC status identifier?
37. EN46002 vs. ISO 13485 - Transition Route
38. Building a new cleanroom - ISO 14644-3 or ISO 14644-4
39. Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
40. ISO 13485:2003 Status: Published
41. Identification and Traceability in Medical Device Tracking - FDA Requirements
42. Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003
43. Looking for Registrar to audit using ISO 13485:2003
44. ISO 13485:2003 Compliance Audit Checklist - Example Attached
45. FDA Quality Audits 21cfr820.22 - Audits by the head of the company not allowed
46. New Clause Structure of ISO 13485:2003
47. ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist
48. To IDE or not to? FDA/CDRH website/guidance documents too hard to understand
49. Accelerated Stability Studies - In vitro Diagnostic Devices
50. Safety Lancets Manufacturer - What is the testing standard used for lancets?
51. Integrating ISO 13485:1996 with ISO 9001:1994
52. CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audits?
53. Iso 11135:1994 - Validation and Control of Ethylene Oxide Sterilization
54. Whats the difference, ISO vs EN ISO Std's
55. ISO 13485 Certification - Class II product - Fluoride-free toothpaste - Records
56. ISO 9001 / ISO 13485 - What is considered a 'documented' procedure?
57. ISO/CD 14969 - Draft of the Guidelines to Implement ISO 14385:2003
58. Where to Document Exclusions per ISO 13485 and ISO 9001
59. Where can I buy ISO 13485?
60. 13485 Calibration Requirements - Requiring a Documented Procedure for control?
61. FMEA vs. Risk Analysis - What are the differences - Medical Devices
62. Microbiological Testing - Bioburden and Identification of Micro-Organisms
63. Conversion from ISO 9001:1994 to ISO 13485:2003
64. Medical Device Component Suppliers - Require ISO 13485 system?
65. ISO13485:2003 - Certification Bodies are accredited by UKAS
66. OTC S/W in Medical Devices (managing obsolescence)
67. ISO 11137:1995 Sterilisation of healthcare products - Amd1:2001
68. Servicing of Wheelchairs (wheel chairs)
69. Cleaning of Miscellaneous Items - Equipment and materials that are reused / recycled
70. Device Labeling Standards: Is ISO 15223:2000 Replacing EN980?
71. FDA Question: Contents of an FDA 510(k) Submission
72. Verification & Validation (V&V) Traceability - What are the benefits and limitations?
73. How many CBs have been accredited to perform ISO 13485:2003?
74. Medical Industry - Nominal Quality Requirements
75. Get your free ($6.95 Value) GMP Pocket Reference
76. Medical Electrical Equipment & UL Approval - Interpreting the Life-Cycle Diagram
77. Transition training for 13485:2003 - Seeking Recommendations and Comments
78. ISO 13485 Procedures - Seeking Examples - Small Manufacturing Company
79. Ratio of Quality vs. Manufacturing Staff in Medical Device Industry
80. Document Issue & Control in ISO9000-3 - Medical software
81. Contract Manufacturing Pre-Qualification? How much 'due diligence' to satisfy the FDA
82. FDA Establishment Registration - Does registration require compliance to the QSR?
83. NCR under MDD - No documented procedure for class I device registration mechanism
84. EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD
85. Life Cycle Approach to Setting Specifications for Biotechnology-Derived Products
86. EU rainbow trout feed regulations
87. Rework Requirements - ISO13485 Part 8.3 vs. FDA QSR
88. Clean Rooms Training - Particle release (personel), Sedmentation velocity of particle
89. Document Change Order - DCO templete which complies with FDA QSR requirements?
90. Planned vs. Unplanned Deviation & Nonconformance
91. Medical Device Directive 92/42 EEC - Clinical Trials - Because the auditor says so?
92. Seeking: Source for IOS International Symbology for OTC products
93. Software Development Plan - Startup Software Development Company - 13485:2003
94. Getting Started - ISO13485:2003 and MDD (Medical Device Directive)
95. Device Defect Training? - Personnel shall be made aware of device defects
96. 13485:2003 7.5.3 and 8.4 - Seeking examples of procedures needed for these clauses
97. 7.4 Purchasing - Query on Indirect Material Qualification
98. Non-sterile - Does anyone know of a universal symbol?
99. Starting ISO 13485:2003 Registration - Introduce Myself
100. Guidance for Understanding ISO 13485
101. Looking for UK DH Document TRS 89 - Diagnostic Imaging and Radiotherapy
102. Management Representative - Is there a requirement for a substitute management rep?
103. ISO 9000:2000 and ISO 13485:2003 impact on the MDD 93/42/EEC
104. ISO 13485:2003 6.4 vs 7.5.1.2.1 - For me these paragraphs are very close
105. Sensitivity vs. Specificity - FDA won't even allow those words
106. Customer notification of processing changes - Class I medical devices
107. Legislation for Safety Devices - Needlestick Safety and Prevention Act (HR 5178)
108. ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix
109. New to ISO13485 and FDA requirements - How and Where do I start?
110. And now, let's add software development - Medical Devices - Applying ISO9001:2000
111. Steam sterilization standards - Temperatures, pressures, and time numbers
112. Changing a UK Notified Body - Anyone with any experience?
113. Rate your FDA Audit Experience
114. What to do once an FDA Inspection is over - Seeking FDA site Link
115. How do I ensure QSR compliance in an FDA company within 12 months
116. When no training is required, How do I document that no training is required?
117. Regulatory requirements to sell and market medical devices in Australia?
118. Line clearance - Routine components in the prep room for universal use
119. 510(k) Document Creation - What are the Rules?
120. All software need validation? Softcopy Specifications copied to CD
121. FDA seeks injunction against a Utah medical device manufacturer
122. ISO 13485 vs. Japan's Pharmaceutical Affairs Law
123. Purchasing process needs for R&D department - IVD Medical Devices
124. Chinese Standards - Specific deviations in adoption of various IEC standards
125. Discontinuing A Medical Device - Support requirements - Class 2 Medical Device
126. Using Rational Unified Process for Medical Device Software
127. ISO 13485 - why keep 9001 registration
128. ISO 13485 : 2003 - When must the transition be completed in Japan?
129. Risk assessment & Product development - All products - Medical device or not?
130. Raw Materials verification - Melt Flow Test - Resins: Customer not Satisfied
131. Implant Contamination - 17-4 SS Devices - Machine Shop
132. What is the transition deadline for ISO 13485:2003?
133. ISO 13485 - 8.2.1, 8.4, 8.5, and 8.5.2/3 - Specific Procedures Needed?
134. Marketing Requirements vs Product Specifications
135. Medical Device: QSR and Clinical Trials and Design Controls
136. 21 CFR 820 QSR 820.25 Statistical Techniques Procedures Requirements
137. ISO 13485 - List of required / needed procedures and records attached
138. What is the most effective way to integrate CAMDCAS requirements into Quality Manual?
139. How to verify SOP training effectivness - Section 6.2.2 in ISO 13485
140. ISO 13485:2003 QMS Flow - I have just put together my first draft
141. How do you control your clinical documents, like surveys, consents, authorizations?
142. Japanese Market - Any special requirements (regulatory or quality)?
143. Audit of medical device company with prototype of product
144. Device Serialization - Generating a unique identifying serial number
145. Technical & Risk Management File - Subcontract manufacturer
146. Draft Revision of EU Medical Devices Directive 93/42/EEC
147. FDA won't take any action as long as you can show effort
148. FDA will not make a company comply with a regulation if it causes undue hardship
149. How do I meet the Medical Devices Risk Assessment requirement?
150. Certifying a PDA as a medical device - (FDA/CE) - For use in the operating room
151. Implementing ISO 13485:2003 - 8.5.1 - Advisory Notices - Recall Procedure
152. Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC)
153. Job shop seeking QMS intends to manufacture devices, is ISO-13485 appropriate?
154. System Requirement - FDA - Software Validation on various OSs
155. Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1)
156. CE Language Requirements on labeling (both device and packaging)
157. MDD class IIa Annex V or VI: specific doubts when implented
158. FDA ASTMF1100 replacement? We want to market an emergency care ventilator
159. Is a component of a pedical screw system considered a finished medical device?
160. IS0 13485:2003, Validation of the application of computer software
161. Class 2b USB enabled diagnostic devices...Clinical trials
162. ISO 13485 Gap Analysis Checklist - Updating ISO 13485 from the 1996 standard to 2003
163. Environmental Control Standards - Sterile medical device manufacturing environment
164. DMR - Device Master Records - What is the best way to structure the DMR
165. Use of CD roms in Labeling of Medical Devices
166. Preparing for initial FDA inspection - What must I do?
167. FDA standard approval list - ANSI/AAMI SP10 - 1992 revision approval
168. Medical Device Directive manufacturer - Wanting to outsource some proceses
169. Disposal requirements - Contamination from waste products and medical device disposal
170. ISO 13485 - Risk Assessment for medical device job shop
171. I've inherited a mess - New to the Regulatory/Quality area - ISO 13485
172. Feedback System (8.2.1) - Requirements for "..establishing a documented procedure..."
173. New Quality Policy - Feedback Wanted
174. Environmental Monitoring - Microbial Identification - Small medical device company
175. Looking for a table that quantifies Likelihood/Probability of occurrence of a hazard
176. ISO 13485: 2003 - Clause 8.4 Analysis of Data - Seeking an example procedure
177. ISO 13485 - Cleanroom Operator Training Requirements
178. Global Medical Device Nomenclature (GMDN) Code
179. ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit
180. Bar coding - Medical device labelling - New Japan requirements
181. Sample MDR and complaints procedure wanted - Medical Devices
182. Revision of MDD, 93/42/EEC - Has the final revision been published?
183. Internal Audit of China factory of Medical devices - need guidance
184. How to Produce a Technical Fle - EC Marking Guidance Needed - MDD 93/42/EEC directive
185. List of Countries Using ISO standards (medical devices in particular)
186. 13488:1996 vs. 13485:2003 Gap Analysis Matrix Spreadsheet
187. ISO 13485, cGMP and ISO 9001 Gap Analysis
188. Virtual Manufacturing and ISO 13485 - Cardiovascular products
189. Export Of Approved Canadian Medical Devices - What export certs are needed
190. ISO 13485 Exclusions - Production-related requirements - Section 7.5
191. Seeking Quality System Input/Output Matrix
192. Documented Procedures for the Issue of Advisory Notices and the FDA (Medical Devices)
193. Tissues of Animal Origins
194. Do Quality System Documents have to be in English (for USFDA onsite inspection)
195. Alcohol Free vs. Alcohol Based Sanitisers - Your Opinions or Experience?
196. Is 13485 applicable to distributors of medical devices?
197. Software validation question - Contract Manufacturer - ISO 13485 implementation
198. Guidance required in relation to refurbishment / remanufacturing of a Medical Device
199. MDR fixes - Resolutions to MDR's for out-of-contract customers
200. Medical Device Release Form
201. Who is the customer for our certified area?
202. ISO 13485:2003 Documentation Requirements for Outsourced Processes and Services
203. Asked to introduce a Blades (Knives) policy into the company
204. Risk Analysis Question - Estimating the likelihood of a hazard occuring
205. What types of Quantitative Results are required in 510(k)
206. Requirement to be registered to ISO 13485 by the end of 2006?
207. Proposed Revision to the Medical Device Directive
208. Qualified Registration Bodies (CMDCAS) one has been suspended
209. A Question of Sorts - Why register to both ISO 13485:2003 and ISO 9001
210. 13485 6.2.2 c) "evaluate the effectiveness of the actions taken" (training)
211. Foley Catheter Color Size Chart
212. Looking for help re: EN980 manufacturing symbol
213. Classification of medical devices in Canada
214. Nuclear Medicine Dose Calibrator Classification (MDD)
215. Medical Device Class I and Class IIa Differences? Inhalator
216. What are the standards needed for an electro-acupuncture device?
217. Specialised Medical device, Pharma & electrical AHESIVES, COATINGS - Seeking Info
218. QSR vs. ISO13485:2003 - Seeking a a comparison list of differences
219. Fast ISO13485:2003 Implementation - What would you do first?
220. Seeking a Comparison Guide - ISO9001 vs. ISO13485
221. MD Directive vs EMC Directive - Totally excluded (for both emissions and immunity)?
222. Canadian Certification Required for a USA-Based Class I Medical Device?
223. JGMP and ISO 13485:2003 - The Japan GMP related to medical device
224. Software Standards for medical devices
225. Classification as medical device or non-medical device?
226. Are you operating a class 9 cleanroom? Share cleanroom monitoring results?
227. MD Compliance for Dummies - Relation between devices, directives and standards
228. Does The FDA oppose the use of Process Flow Charts?
229. Do we provide servicing according to ISO 13485:2003
230. CE certificate validity - Signing employee has left the company
231. Regulatory Affairs - What does it take to be a Regulatory Affairs?
232. What are the major differences between ISO 13485:1996 and ISO 13485:2003?
233. Any feelings on how far back the FDA looks into documentation?
234. Iso 15223 Or En 980?? What standard should be used in CE technical file?
235. BS 7320 Sharps Containers - Seeking Information
236. STEDs - Experience submitting STEDs for low / medium risk devices?
237. Ownbranding or placing on market without CE mark
238. Japanese Regulations for Medical Devices - Three Questions
239. Efficient approach to convert Quality System from ISO 13485:2000 to ISO 13485:2003
240. ASQ Biomedical Division "The New Basics of Quality" on Oct.27 & 28 in Waltham, MA
241. ISO 13485:2003 Section 6.2.1 and 6.2.2 - Apply only to people working on products?
242. Can somebody help me to identify the 27 ISO 13485:2003 procedures?
243. Vigilance System - Seeking example Procedure and Implementation Advice
244. Subcontractor in terms of CAN/CAS 13485:2003 CMDCAS vs. DIN EN ISO 13485:2003
245. Having an Extension audit for the purpose of getting the CE-mark for our product
246. Risk management of collagen products
247. Going from ISO 9001 to ISO 13485 - How do I make a Quality manual?
248. Engineering History Record for development - Need definition
249. Outsourced Processes - Not all identified in the Quality Manual
250. Has AAMI TIR 14969 (ISO TR 14969) been released for ISO 13485:2003?