The Elsmar Cove Forum > ISO (International Organization for Standardization) Standards > ISO 13485 - Medical Devices

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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. Graphical Symbols - EN 980 - Labeling of medical devices and EN 60601-1 symbols
8. Systems Requirements Mandated by EN46001 and EN46002
9. Purchasing Procedure - QSR §820.50 and ISO 9001:1994 Clause 4.6
10. Process monitoring - Stationary and portable oxygen units
11. Verification Activities - Clinical Medical device manufacturer
12. Continuous Certification - ISO 9001 Certified EN4600 - Why the 3 year recert audit?
13. ISO 13485:1996 - EN 46001 - Medical devices - Particular requirements - ISO 9001
14. Where can I buy EN46000?
15. Passivation Validation - Is passivation is considered a "special" process by the FDA?
16. FDA QSRs and ISO 9001:2000 - CFR 21 Part 820 and CFR 21 Part 58
17. QSR Purchasing Controls governing evaluation and use of consultants
18. History and Current Status of ISO 13485?
19. Particulate On Final Implantable Devices
20. I would like to know the requirements for USFDA approval
21. Looking at 21 CFR 820.20 which calls out in section (d) for Quality Planning
22. En 550/554 - The European Commission Standards Harmonization
23. Software Validation - CAD-type program that will produce Engineering drawings
24. 21CFR820 vs. ISO 9000:2000 - Cross Reference Matrix Attached
25. Food and Drink in Production Areas - Manufacturer of FDA analytical and diagnostic
26. What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820?
27. cGMPs, Quality Requlations for Drug Manufacturer's & Their Suppliers
28. Quality Regulations for Drug Manufacturers & Their Suppliers
29. Clinical Trials in Europe - What is the "competent authority" in Italy?
30. Notified Bodies - Notifying Customers when Changing Registrars?
31. Pursuing certification to ISO 13485 (actually 13488)
32. Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000
33. Micro Contamination - Emoderivates (producing albumin, etc from human plasma)
34. Where can I buy ISO 13485?
35. ISO 13485 and ISO 17025 Interface - Laboratory vs. Parent Company
36. Anyone know Coca Cola's (Coke) QA system?
37. Finished product visual status - Each box must have a QC status identifier?
38. EN46002 vs. ISO 13485 - Transition Route
39. Building a new cleanroom - ISO 14644-3 or ISO 14644-4
40. Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
41. ISO 13485:2003 Status: Published
42. Identification and Traceability in Medical Device Tracking - FDA Requirements
43. Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003
44. Looking for Registrar to audit using ISO 13485:2003
45. ISO 13485:2003 Compliance Audit Checklist - Example Attached
46. FDA Quality Audits 21cfr820.22 - Audits by the head of the company not allowed
47. New Clause Structure of ISO 13485:2003
48. ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist
49. To IDE or not to? FDA/CDRH website/guidance documents too hard to understand
50. Accelerated Stability Studies - In vitro Diagnostic Devices
51. Safety Lancets Manufacturer - What is the testing standard used for lancets?
52. Integrating ISO 13485:1996 with ISO 9001:1994
53. CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audits?
54. Iso 11135:1994 - Validation and Control of Ethylene Oxide Sterilization
55. Whats the difference, ISO vs EN ISO Std's
56. Applicability of Risk Management for Medical Devices - ISO 14971:2000
57. ISO 13485 Certification - Class II product - Fluoride-free toothpaste - Records
58. ISO 9001 / ISO 13485 - What is considered a 'documented' procedure?
59. ISO/CD 14969 - Draft of the Guidelines to Implement ISO 14385:2003
60. Where to Document Exclusions per ISO 13485 and ISO 9001
61. Where can I buy ISO 13485?
62. 13485 Calibration Requirements - Requiring a Documented Procedure for control?
63. FMEA vs. Risk Analysis - What are the differences - Medical Devices
64. Microbiological Testing - Bioburden and Identification of Micro-Organisms
65. Conversion from ISO 9001:1994 to ISO 13485:2003
66. Medical Device Component Suppliers - Require ISO 13485 system?
67. ISO13485:2003 - Certification Bodies are accredited by UKAS
68. OTC S/W in Medical Devices (managing obsolescence)
69. ISO 11137:1995 Sterilisation of healthcare products - Amd1:2001
70. Servicing of Wheelchairs (wheel chairs)
71. Cleaning of Miscellaneous Items - Equipment and materials that are reused / recycled
72. Device Labeling Standards: Is ISO 15223:2000 Replacing EN980?
73. FDA Question: Contents of an FDA 510(k) Submission
74. Verification & Validation (V&V) Traceability - What are the benefits and limitations?
75. How many CBs have been accredited to perform ISO 13485:2003?
76. Medical Industry - Nominal Quality Requirements
77. Get your free ($6.95 Value) GMP Pocket Reference
78. Medical Electrical Equipment & UL Approval - Interpreting the Life-Cycle Diagram
79. Transition training for 13485:2003 - Seeking Recommendations and Comments
80. ISO 13485 Procedures - Seeking Examples - Small Manufacturing Company
81. Ratio of Quality vs. Manufacturing Staff in Medical Device Industry
82. Document Issue & Control in ISO9000-3 - Medical software
83. Contract Manufacturing Pre-Qualification? How much 'due diligence' to satisfy the FDA
84. FDA Establishment Registration - Does registration require compliance to the QSR?
85. NCR under MDD - No documented procedure for class I device registration mechanism
86. EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD
87. Life Cycle Approach to Setting Specifications for Biotechnology-Derived Products
88. EU rainbow trout feed regulations
89. Rework Requirements - ISO13485 Part 8.3 vs. FDA QSR
90. ISO 14971 replaces EN 1441 - Risk Analysis and Technical Files/Device Master Files
91. Clean Rooms Training - Particle release (personel), Sedmentation velocity of particle
92. Document Change Order - DCO templete which complies with FDA QSR requirements?
93. Planned vs. Unplanned Deviation & Nonconformance
94. Medical Device Directive 92/42 EEC - Clinical Trials - Because the auditor says so?
95. Seeking: Source for IOS International Symbology for OTC products
96. Software Development Plan - Startup Software Development Company - 13485:2003
97. Getting Started - ISO13485:2003 and MDD (Medical Device Directive)
98. Device Defect Training? - Personnel shall be made aware of device defects
99. Risk Management ISO 14971 - Samples and How to Go about it
100. 13485:2003 7.5.3 and 8.4 - Seeking examples of procedures needed for these clauses
101. 7.4 Purchasing - Query on Indirect Material Qualification
102. Non-sterile - Does anyone know of a universal symbol?
103. Starting ISO 13485:2003 Registration - Introduce Myself
104. Guidance for Understanding ISO 13485
105. ISO 13485 (EN 46000) or ISO 9001 - Which Standard? Sterilization within a Hospital
106. Looking for UK DH Document TRS 89 - Diagnostic Imaging and Radiotherapy
107. Management Representative - Is there a requirement for a substitute management rep?
108. ISO 9000:2000 and ISO 13485:2003 impact on the MDD 93/42/EEC
109. ISO 13485:2003 6.4 vs 7.5.1.2.1 - For me these paragraphs are very close
110. Sensitivity vs. Specificity - FDA won't even allow those words
111. Customer notification of processing changes - Class I medical devices
112. Legislation for Safety Devices - Needlestick Safety and Prevention Act (HR 5178)
113. ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix
114. New to ISO13485 and FDA requirements - How and Where do I start?
115. And now, let's add software development - Medical Devices - Applying ISO9001:2000
116. Steam sterilization standards - Temperatures, pressures, and time numbers
117. Changing a UK Notified Body - Anyone with any experience?
118. Rate your FDA Audit Experience
119. What to do once an FDA Inspection is over - Seeking FDA site Link
120. How do I ensure QSR compliance in an FDA company within 12 months
121. When no training is required, How do I document that no training is required?
122. Regulatory requirements to sell and market medical devices in Australia?
123. Line clearance - Routine components in the prep room for universal use
124. 510(k) Document Creation - What are the Rules?
125. All software need validation? Softcopy Specifications copied to CD
126. FDA seeks injunction against a Utah medical device manufacturer
127. ISO14971:2001 - Risk Management for Medical Devices - Help need copy
128. ISO 13485 vs. Japan's Pharmacutical Affairs Law
129. Purchasing process needs for R&D department - IVD Medical Devices
130. Chinese Standards - Specific deviations in adoption of various IEC standards
131. Discontinuing A Medical Device - Support requirements - Class 2 Medical Device
132. Using Rational Unified Process for Medical Device Software
133. ISO 13485 - why keep 9001 registration
134. ISO 13485 : 2003 - When must the transition be completed in Japan?
135. Risk assessment & Product development - All products - Medical device or not?
136. Raw Materials verification - Melt Flow Test - Resins: Customer not Satisfied
137. Implant Contamination - 17-4 SS Devices - Machine Shop
138. What is the transition deadline for ISO 13485:2003?
139. ISO 13485 - 8.2.1, 8.4, 8.5, and 8.5.2/3 - Specific Procedures Needed?
140. Marketing Requirements vs Product Specifications
141. Medical Device: QSR and Clinical Trials and Design Controls
142. 21 CFR 820 QSR 820.25 Statistical Techniques Procedures Requirements
143. ISO 13485 - List of required / needed procedures and records attached
144. What is the most effective way to integrate CAMDCAS requirements into Quality Manual?
145. How to verify SOP training effectivness - Section 6.2.2 in ISO 13485
146. ISO 13485:2003 QMS Flow - I have just put together my first draft
147. How do you control your clinical documents, like surveys, consents, authorizations?
148. Japanese Market - Any special requirements (regulatory or quality)?
149. Audit of medical device company with prototype of product
150. Device Serialization - Generating a unique identifying serial number
151. Technical & Risk Management File - Subcontract manufacturer
152. Draft Revision of EU Medical Devices Directive 93/42/EEC
153. FDA won't take any action as long as you can show effort
154. FDA will not make a company comply with a regulation if it causes undue hardship
155. How do I meet the Medical Devices Risk Assessment requirement?
156. Certifying a PDA as a medical device - (FDA/CE) - For use in the operating room
157. Implementing ISO 13485:2003 - 8.5.1 - Advisory Notices - Recall Procedure
158. Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC)
159. Job shop seeking QMS intends to manufacture devices, is ISO-13485 appropriate?
160. System Requirement - FDA - Software Validation on various OSs
161. Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1)
162. CE Language Requirements on labeling (both device and packaging)
163. MDD class IIa Annex V or VI: specific doubts when implented
164. FDA ASTMF1100 replacement? We want to market an emergency care ventilator
165. Is a component of a pedical screw system considered a finished medical device?
166. IS0 13485:2003, Validation of the application of computer software
167. Class 2b USB enabled diagnostic devices...Clinical trials
168. ISO 13485 Gap Analysis Checklist - Updating ISO 13485 from the 1996 standard to 2003
169. Environmental Control Standards - Sterile medical device manufacturing environment
170. ISO 13485 & ISO 14971 - Requirements for risk management
171. DMR - Device Master Records - What is the best way to structure the DMR
172. Use of CD roms in Labeling of Medical Devices
173. Preparing for initial FDA inspection - What must I do?
174. FDA standard approval list - ANSI/AAMI SP10 - 1992 revision approval
175. Medical Device Directive manufacturer - Wanting to outsource some proceses
176. Disposal requirements - Contamination from waste products and medical device disposal
177. ISO 13485 - Risk Assessment for medical device job shop
178. I've inherited a mess - New to the Regulatory/Quality area - ISO 13485
179. Feedback System (8.2.1) - Requirements for "..establishing a documented procedure..."
180. New Quality Policy - Feedback Wanted
181. Environmental Monitoring - Microbial Identification - Small medical device company
182. Looking for a table that quantifies Likelihood/Probability of occurrence of a hazard
183. ISO 13485: 2003 - Clause 8.4 Analysis of Data - Seeking an example procedure
184. ISO 13485 - Cleanroom Operator Training Requirements
185. Global Medical Device Nomenclature (GMDN) Code
186. Ansi/aami/iso13485:2003 + Iso14971:2000 + Iec60601-1-4:2000 + Mdd93/42/eec
187. ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit
188. Bar coding - Medical device labelling - New Japan requirements
189. Sample MDR and complaints procedure wanted - Medical Devices
190. Revision of MDD, 93/42/EEC - Has the final revision been published?
191. Internal Audit of China factory of Medical devices - need guidance
192. How to Produce a Technical Fle - EC Marking Guidance Needed - MDD 93/42/EEC directive
193. List of Countries Using ISO standards (medical devices in particular)
194. 13488:1996 vs. 13485:2003 Gap Analysis Matrix Spreadsheet
195. ISO 13485, cGMP and ISO 9001 Gap Analysis
196. Virtual Manufacturing and ISO 13485 - Cardiovascular products
197. Export Of Approved Canadian Medical Devices - What export certs are needed
198. ISO 13485 Exclusions - Production-related requirements - Section 7.5
199. Seeking Quality System Input/Output Matrix
200. Documented Procedures for the Issue of Advisory Notices and the FDA (Medical Devices)
201. Tissues of Animal Origins
202. Do Quality System Documents have to be in English (for USFDA onsite inspection)
203. Alcohol Free vs. Alcohol Based Sanitisers - Your Opinions or Experience?
204. Is 13485 applicable to distributors of medical devices?
205. Software validation question - Contract Manufacturer - ISO 13485 implementation
206. Guidance required in relation to refurbishment / remanufacturing of a Medical Device
207. MDR fixes - Resolutions to MDR's for out-of-contract customers
208. Medical Device Release Form
209. Who is the customer for our certified area?
210. ISO 13485:2003 Documentation Requirements for Outsouced Processes and Services
211. Asked to introduce a Blades (Knives) policy into the company
212. Risk Analysis Question - Estimating the likelihood of a hazard occuring
213. Medical Device EMC requirements - Canada - Testing to FCC part 18, EN 55011, EN 60601
214. What types of Quantitative Results are required in 510(k)
215. Requirement to be registered to ISO 13485 by the end of 2006?
216. Proposed Revision to the Medical Device Directive
217. Qualified Registration Bodies (CMDCAS) one has been suspended
218. A Question of Sorts - Why register to both ISO 13485:2003 and ISO 9001
219. 13485 6.2.2 c) "evaluate the effectiveness of the actions taken" (training)
220. Foley Catheter Color Size Chart
221. Looking for help re: EN980 manufacturing symbol
222. Classification of medical devices in Canada
223. Sterilization Validation ISO 14937 - Sterilizer that uses EO gas diffusion
224. Nuclear Medicine Dose Calibrator Classification (MDD)
225. Do we require compliance to ISO 14971 (Risk Management)?
226. Medical Device Class I and Class IIa Differences? Inhalator
227. What are the standards needed for an electro-acupuncture device?
228. Specialised Medical device, Pharma & electrical AHESIVES, COATINGS - Seeking Info
229. QSR vs. ISO13485:2003 - Seeking a a comparison list of differences
230. Fast ISO13485:2003 Implementation - What would you do first?
231. Seeking a Comparison Guide - ISO9001 vs. ISO13485
232. MD Directive vs EMC Directive - Totally excluded (for both emissions and immunity)?
233. Canadian Certification Required for a USA-Based Class I Medical Device?
234. JGMP and ISO 13485:2003 - The Japan GMP related to medical device
235. ISO 14971 and 13485 - Is ISO14971 just a supplement to ISO13485?
236. Software Standards for medical devices
237. Classification as medical device or non-medical device?
238. Are you operating a class 9 cleanroom? Share cleanroom monitoring results?
239. MD Compliance for Dummies - Relation between devices, directives and standards
240. Does The FDA oppose the use of Process Flow Charts?
241. Do we provide servicing according to ISO 13485:2003
242. CE certificate validity - Signing employee has left the company
243. Regulatory Affairs - What does it take to be a Regulatory Affairs?
244. What are the major differences between ISO 13485:1996 and ISO 13485:2003?
245. Any feelings on how far back the FDA looks into documentation?
246. Iso 15223 Or En 980?? What standard should be used in CE technical file?
247. BS 7320 Sharps Containers - Seeking Information
248. IEC 60601-1 for low voltage medical devices? DC power less than 10V
249. STEDs - Experience submitting STEDs for low / medium risk devices?
250. Ownbranding or placing on market without CE mark