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View Full Version : ISO 13485 - Medical Devices - Quality Management Systems

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  1. Health, hygiene and contamination control procedure for a sensor cable product.
  2. Failure to follow QMS procedures
  3. Focused CAPA on Missing Finished Nonconforming Product
  4. Preparations for an interview with a company CEO
  5. Medical Device (Gloves) Stability (Aging) testing and Shelf Life
  6. Symbol Colours and Sizes on Medical Devices
  7. QA responsible for selection of tools such as document control systems?
  8. Pest Control procedure requirements? Pesticide / Sprays in Production Areas
  9. Document Control at Suppliers - Control of External Documents
  10. How is your Regulatory Department structured?
  11. UL Listing - Do you find UL Listing necessary? Medical Devices
  12. Chinese supplier called Dalian Sunny - Titanium
  13. Cleanliness Specifications that apply to non-sterile medical devices
  14. What is 'output of risk management' in ISO 13485, Cl 7.3.2(e).?
  15. Vigilance - Public database of Vigilance reports (similar to FDA MAUDE database)?
  16. Determining a New Product Bioburden Limit
  17. GMDN / ISO15225: When should it be applied?
  18. Updating Certificate of Foreign Government (CFG's)
  19. Gap Analysis ISO 13485 and Singapore GDPMDS
  20. Medical Device Regulatory Guidelines – Singapore's Health Sciences Authority (HSA)
  21. Medical Device Registration - New Zealand
  22. Requirements of Contract Manufacturing in respect to GMP?
  23. Whether the medicine spoon, medicine dropper and NASAL ASPIRATOR are medical devices
  24. Supplier Qualification Audit on site or off site?
  25. Is a vendor of Class ll (Orthodontic Adhesive) required to be ISO certified
  26. Health Canada to accept Summary Technical Documentation (STED) for Class III & IV
  27. ISO 13485 Clause 7.4 Purchase Order Requirements Question
  28. Australia’s TGA - IVD Regulations have been published
  29. Medical Gas Change Over Unit - Which Standard to use?
  30. ISO 13485 Certification - Single ISO certificate for two different business entities?
  31. Supplier Audit - Supplier of Haemodialysis machines
  32. GHTF - Guidance on QMS Audits at Multiple Sites / Regulatory Auditing Strategy
  33. Health Canada Device Classification - Close-off clip for use with a tubing set
  34. Medical Device Regulatory Guidelines – TFDA (Tanzania Food and Drugs Authority)
  35. DEHP vs. DINP as Plasticizer in PVC (Emerging Health hazard)
  36. WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins
  37. ISO 13485 Design Control Procedure for Virtual Manufacturer wanted
  38. ISO 13485 Risk Analysis - Class II Medical Device Engineering Changes
  39. ISO 25424:2009 Sterilization of Medical Devices Low Temperature Steam & Formaldehyde
  40. Maintaining Dual Standards ISO 9001 and ISO 13485 - Contract Manufacturer
  41. Documentation of OEM Device - Technical File for a Class IIa Medical Device
  42. Laboratory Testing for AS4259-1995 & AS5356-1:2004 - Seeking Test Lab
  43. ISO 13485 - Would it be beneficial to get certified under my circumstances?
  44. Grandfathering Rules for an Old Organization - ISO 13485 Requirements
  45. Implement FAI process in my Incoming (Receiving) Inspection Procedure
  46. Bioburden and Product Labels - VD Max studies on all the BOMs
  47. Implementing Risk Management for Contract Manufacturer - ISO 13485
  48. Microbial Limit (Bioburden)on dry nonwoven that used for making Hand sanitizing wipes
  49. Web Address or the Full Street and ZIP/Postcode Address for FPR Labeling?
  50. Celebrating Registration - ISO 13485
  51. Keepsakes...Sample retention requirements?
  52. Medical Devices Registering (Registration) Procedure in South Africa
  53. Standard for Microbial Limits for a Combination Device - Impregnated Retraction Cord
  54. Labeling Control and trouble with labelers not following procedure
  55. Validity of Old Biocompatibility Data (1999) - Catheter
  56. Sequence and Interaction Figure
  57. Control of Outsourced Processes (not properly described in the quality manual)
  58. Good Refurbishment Guidelines for Medical Devices
  59. Risk Management (again) for a Contract Manufacturer
  60. Medical Device Labeling: Country Code or Language Code?
  61. The US's FDA and other Medical Device Related Forums
  62. Biocompatibility of Implantable Component - What testing, if any?
  63. Part & Process Approval in Medical Devices
  64. Procedure for Completing Medical Device Project Plans
  65. Quality Manual shall Outline Structure of Documentation - Clause 4.2.2
  66. Design Input/Output Form - Your feedback appreciated
  67. Tracking Number of Uses of a Medical Device that can be Sterilized by the User
  68. Supplier Performance of "non-key" Supplier
  69. Regulatory Requirements are for selling Medical Devices in the Ukraine?
  70. Information about Risk Management in ISO9001:2008
  71. Dedicated SOP for Shipments issue
  72. Cleaning procedure for a cleanroom class 7 & 8.
  73. Requirements on how long you have to keep Spare Parts for Medical Device Repairs
  74. Medical Device Maintenance Regulations
  75. TGA - Application Fees - Exporting Medical Devices into Australia market
  76. Orthopaedic Implant & Biocompatibity
  77. AQL Practice in the Medical Device
  78. FOC (3 lots) - First of Code - Are you still doing 3 lots for FOC?
  79. Medical Device Labelling Regulatory Requirements - Barcode Formats
  80. Use of materials derived from animal sources
  81. Cost or Fees to Register Medical Devices in Venezuela
  82. Quality System requirements for repair of medical devices.
  83. Software Validation - Pre submission for an implantable 'surgical mesh' device
  84. Use of Antimicrobial Inhibitors in Medical Devices
  85. Are there Summaries for Sterilization Standards?
  86. Co-Development Process - Separating our development activities from our customer's
  87. Symbol or Label requirements for "Demo Instrument"?
  88. Missed Quarterly Dose Audit! Sterilization Validation of Medical Devices
  89. ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthcare
  90. ISO 10993-1:2009 incorporating Risk Management published by ISO
  91. How to document rework being completed at Suppliers on Medical Devices?
  92. Implementation Schedule in EU for ISO 10993-7:2008 - Transition period?