• Biocompatibility - Hospital Bed
• Usability Engineering ISO 62366:2008 - Medical Devices
• Particulate Release Testing on Catheters
• Use of phthalates - MDD 2007/47/EC
• GMDN (Global Medical Device Nomenclature) Codes
• New Harmonized Standards MDD and IVDD
• CE Mark / TCF (Technical Construction File) File sample
• CE marking on medical device components/replacement parts
• IEC 60601-1 3rd Edition Recognition in Canada
• Comparison of ISO 14155 to FDA Good Clinical Practice
• CB Scheme IEC 61010 / IEC 60601...+ NRTL mark
• Medical Device Directive, Conversion from class IIb to class III
• Who can do a noise emission test for us?
• PED (Pressure Equipment Directive) Certification - We hold an ASME 'S' stamp
• CE Mark "piggybacking" on suppliers technical files - Looking for contract example
• CE Marking for Wood Product - One for each product?, Self Declare?
• CE Marking regulation of construction products starting on January 2009
• IFU (Instructions for Use) - Labeling Requirements
• Is CE marking required for power resistors?
• Medical Device "accessory" - Blood pressure monitor (BPM) power supply
• Device Classification Issue - Pacemaker, pacemaker lead and pacemaker programmer
• Advice Please regarding CE Marking requirements for Printing Press
• LCD-TFT screen with player for publicity film - Commercial device CE Marking
• CE marking with or without NB (Notified Body)
• Sterilization of Implantable bone screws - ISO 13485 and CE Mark
• Usability Engineering File - Looking for an example/template
• CE Marking for Research Instruments - Small Company - Class II Medical Device
• On/OFF switch received from supplier - No CE marking but with Certificate
• New List of Medical Device Harmonized Standards - MDD
• CE Mark - Timber/Wood Working Equipment
• Relationship of IEC 60601-1-6:2006 vs. IEC 60601-1 3rd Edition
• Variant - Definition within Medical Device Directive
• Low Voltage Directive 2006/95/EC - Is Notified Body (NB) needed?
• New edition of IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3
• CE for different products
• Technical file for Software that's merely an interface for doctor to visualize data
• Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required?
• Certificate of Conformity? Supplier incoming material inspection
• CE marking - Annex V vs Annex II
• Harmonization date of IEC 60601-1 , 3rd Edition
• CE Marking for Baby Crib Mattress - Which Directive? Is self declaration enough?
• Flame Class for Enclosure of Medical Equipment
• Declaration of Conformity - Conformance with more than one directive
• Is CE Mark required for Hand Sanitizers to be sold in Europe ?
• Is CE Re-Certification Necessary? - Add internal cooling fan
• Technical Agreement for the CE Mark - Essential Requirements Checklist
• Vigilance Report Required for Incidents Outside the EU?
• CE Marking Current Status with MOD
• Non CE marked medical devices /clinical investigation
• Lot numbers in Declaration of Conformity
• Implications on the Legal Status of the "Declaration of Conformity"
• CE Mark Size Requirement - Class I Medical Device
• CE for assembled products based on OEM which has its own CE
• Medical Device or not - Throat lozenge
• ENEC Mark - How is it related to the CE Mark and is it Compulsory?
• Accessory (CE required) or Spare Part (no CE)
• Comparison between MDD and AIMD
• CE Mark Requirements for Dentist Chair
• Sales in Europe of CE marked Medical devices with sister company
• CE Marking Process - Obligations of an Authorized Representative
• Finally! CE Mark capable
• CE marking of products - How do you know if your product requires it?
• Medical Device Vigilance System Requirements - CE Mark Products
• CB (Certification Body /Competent Body) and CE (European Mark of Conformity)?
• Class I Medical Device - What is in a CE Marking Self-Declaration
• Experience with IMB as Competent Authority of Drug Device Combination Products?
• Independent authorized CE Marking representative in UK or EU - Class 1 Medical Device
• CE Marking outside of Europe?
• CE mark for photo frames albums for UK
• Active Medical Devices - An example of an Active Medical Device and Definition
• New MDD Consolidated Version Published
• Minimizing cost of product certification - int/ext CE certified Powersupply Unit?
• CE Marking Specific Discussion or Forum Web Sites
• What is the Process for CE Marking a Flight Simulator
• Multiple Applied Parts - Cardiac Floating (CF), Body Floating (BF) Marking
• Medical Device (MedDev) Vigilance Guidelines for Importers into the UE
• CE Marking Question - Class IIa device by complying with Annex V & VII
• MDD for Drug Product for CE Marking
• CE Mark for Surgical Gowns & Surgical Drapes
• CE-Mark for Ceramic Tiles
• Revision of MDD 93/42/EEC, AIMD 90/385/EEC and BPD 98/8/EC published: 2007/47/EC
• Requirements for CE marking a component to go into an assembly (PED)
• International Symbols in Metrology and Calibration
• CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc.
• Which Harmonized Standard to which Essential Requirement
• Requirements for Declaration of Conformity - Compliance to MDD
• CE Marking Issue- this seems illegal to me...
• Application of ISO 14155 Clinical Trials Investigations
• CE-marked devices require EN ISO 14971 risk management
• European MDD Classification of Medical Devices (Risk Class)
• Requirements for Updating a Medical Device Technical File
• MDD confomity assessment - ISO 13485 registration counts for nothing???
• The status of the 2005 ammendments to the MDD (Medical Device Directive)?
• A need for CE Marking? Structural Steel
• Preparing the Technical File for a 12 Lead ECG Monitor
• What function normally updates/maintains the Technical File?
• Non-sterile liquid bandage as Class 1 - Anyone concur or disagree?
• Big Shipping Error - Shipped without the CE mark on them - Need advice!
• CE Marking for cast iron, cast steel, and bronze Industrial Valves
• CE Mark requirements for Class IIA MDs - European medical devices importers
• CE marking and RUO (Research Use Only) products - Distributing in vitro products
• What Class 1 Medical Device Registration is required to sell in Poland
• CE mark - Trying to determine if our product needs CE approval
• Radio & Telecommunications Terminal Equipment Directive 1999/5/EC
• CE requirement for software importer / reseller - Class II for FDA and Health Canada
• CE Marking for Class I Medical Devices - Self-declare CE marking?
• Instructions for Use - Ob/Gyn products sold in Europe - CE mark and the NB number
• Website Document Control - Medical Device Product
• CE Mark Database akin to 510 (k) database?
• CE Mark Myths - The Medical Device Directive's Seven Major Myths
• CE marking, required for prototypes? New technology lighting source
• MDD and CE Mark Registration - What will the technical expert look for?
• Obtaining the CE Mark from TUV
• CE Mark & Harmonized Standards - Article 5.1, MDD - Has anyone challanged this?
• CE Mark & Harmonized Standards
• CE Mark Question, Manufactuerer or distributor, steps the same?
• CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11
• CE marking - Medical Device - Must have our name and address on it?
• CE Mark - FDA - Class I traction systems - What is involved and how long does it take
• CE Mark Medical Devices - Annexes II, IV, V and VI
• What's the gap between CE-marking and FDA's approval?
• Getting CE Mark - What is the process of getting it?
• Is ISO 13485:2003 Certification neccessary to get the CE Mark?
• CE Mark Auditing - All they had for CE was a written Technical Justification
• ISO 9001 vs. CE Mark European directives

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