• Italian Ministry of Health Medical Device Databank regulation
• Leakage current from battery - IEC 60601-1 Medical Device
• Recall or advisory notice sufficient for software
• Uneasiness regarding medical device responsibility... Multi-company activity chains
• What are the next steps for a medical device entering Canada?
• Veterinary device is medical device or not?
• SOP's (Standard Operating Procedures) - the "write/right" way
• Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfaction
• ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix
• Application of Risk Management - ISO 14971:2007(E) Medical Devices
• Process Audits for Medical Devices
• Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements
• MDD Class III Exclusions
• Luer taper tolerances - 6% or otherwise - Dimensional accuracy
• 510(k) filing for GSM (Global System for Mobile Communication) technology?
• Distributor Requirements for Sterile Disposable Medical Devices
• How to sell Veterinary Devices to Canada
• Defining Product Lifetime - Medical Devices
• Rework vs. Repair - ISO 13485 definition
• Implementing Change Control on Company Website
• Applicability of REACH in medical device
• UMDNS of air compressor nebulizer
• Does anyone have a Cleanroom audit checklist?
• Supplier name on label of IVD packaging
• Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (a)
• Process Interaction Map for ISO 13485
• Need Advice: Regulatory Requirements Audits
• ISO 13485 Audit requirements - Manufacturing requirements in draft?
• New Directive Outlined for Medical Devices by ASEAN
• Supplier Control: Medical software "module"
• Statistical Process Control (SPC) for Clean Room Environments
• Procedure for Recall of Medical Devices - Where?
• Graphical Symbols - EN 980 - Labeling of medical devices and EN 60601-1 symbols
• Appropriate FMECA handling of cascading failures?
• CE Language Requirements on labeling (both device and packaging)
• Polyester Biocompatibility standards - Anyone here have any experience?
• Italian Device Classification - CND
• Official Languages of the European Community
• Medical Device Adhesive with USP class VI, suited for oral 'use'
• How to Audit Outsource process (New Trainee Auditor)
• Production and Service Provision - AS9100 vs. ISO 13485 - Numbering Issues
• CE Marking Basics - Laser - I am new to Regulatory
• ISO 13485 and network security protection - Medical device manufacturer
• Utility - Electrical operation qualification protocol for validation
• CMDCAS (Canadian Medical Devices Conformity Assessment System) for drugs
• Medical Device Regulations for CIS Countries
• Risk of fire in an Oxygen rich environment - Fire Prevention - IEC 60601-1
• Introduction of Compulsory Bar Coding of Medical Devices in the US?
• Protocol to validate the use of Electronic Records like DHRs, NCMRs, Validations
• The key differences between EN 46001 and ISO 13485
• Best Risk Analysis Approach (ISO 14971) - Class IIa medical devices
• Guidelines that specify the frequency of ETO Sterilizer Re-Validation
• Biocompatibility testing centre in Montreal QC ?
• Contradictions in the reporting timelines of IVD Directive and MEDDEV 2.12-1 Rev 5
• Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
• FDA Part 820 Quality System Regulation - 820.198 Complaint files
• I will be an ISO 13485 Auditor soon - Your suggestions are appreciated
• Process Interaction Chart example as required by ISO 13485 2003
• Quality System Database Validation - FDA's General Principles of Software Validation
• Medical device registration process in Brazil - Anvisa
• FDA Regulation Training Materials
• Are artificial teeth medical devices? If so, which class do they belong to?
• ISO 10993 - Required Testing - Can I follow the literature route?
• Could We use electronic signatures rather than manual sign offs?
• USB Port (Signal I/O) Isolation as per IEC60601-1 - Medical Device
• USB Port Isolation as per IEC60601-1 - Medical Device
• Integrated CAPA database for internal audit and nonconforming material
• Device Master Record requirements - wrong approach?
• CLIA vs. QSR Audit Differences - and - Audit templates for CLIA audits
• Difficult Inspection Level/AQL - Verifying it is the correct part
• Registration/Homologation Colombia & Cuba - Class I and IIa medical devices
• Supplier Quality vs. Supplied Material Quality
• Tough Decision - Not a medical device anywhere except US and Canada
• Raw Material Specifications - Medical Device Company
• ISO 13485 implementation - Other required standards and guides
• X-ray's light testing - What is the standard to test the X-ray light brightness?
• Keep current ISO 13485 registrar AND add new for CMDCAS
• GMP Stores qualification/validation plan or protocol - New Store requirements
• Medical device with NON medical PC - USB galvanic insulation
• Please help me to convert from ISO9001 to ISO13485
• Clean Room - Standards or some type of Clean Room Validation - ISO 13485
• In-Process Non-Conformance Report Contents
• Turkish factory under US umbrella - Small medical device manufacturer
• Filing of Registration Documents in an organised or consistent way
• External Document Control Procedure advice wanted
• Supplier audit - Are they asking for too much documentation?
• JMDN (Japanese Medical Device Nomenclature) codes list needed
• EtO Sterilization - DIN/EN 550 - ISO 11135
• ETO Sterilization - Process monitoring and out-inspection
• Suitable Sterilization Cycle to achieve Sterility Assurance Level of <10-6
• Gap analysis for ISO 11135-1994 and 2007
• Medical Device Training - Looking for suggestions on Medical Device training
• The air kerma measuring device - Does anyone know anything about it?
• ISO 13485 IAF Medical Device Conformity Assessment System IAF-MDCAS
• Q - Definitions of all the Q's - QM, QMS, QP, QSR, etc.
• BioHazard Cleaning of Returned Devices - Small Medical Device company - Need Ideas
• Is a Test or Prototype Implant a Medical Device per ISO 13485 definition?
• Cleaning standards for Medical Devices - Implants - Cleaning Validation
• IEC 62304 compliance status - Is it mandatory for 510(k) submittal?
• Does anyone have a template for Validation Master Plan to share?
• Approved Supplier List ISO 13485
• Effectiveness of Supplier Corrective Actions
• Asian Harmonization Working Party to hold meeting on Nov 5, 6 in Delhi
• Changes to QRI (Quick Reference Instruction)? What I can or cannot change
• Gulf Cooperation Council (GCC) Common Market for Medical Devices?
• Bioburden testing for non-sterile products - ISO 11737
• ISO 13485 Risk Management for Contract Manufacturer
• Any experience with Clinivation??
• Repairs vs. Scrapping for Parts and Serial Numbers
• Ownership of ISO 13485:2003 company changing - Anyone to update?
• Does EN 60601-1 include 60601-1-2 from a contract point of view
• Medical Device and Importation Requirements for Tradeshows in EU
• Medical Device missing Repair Record - FDA Audit
• How to verify the SAL (sterilie acceptable level) is 10-6 for ETO Sterilization
• MDD Classification - Marketer Has Misclassified A Product?
• Medical Device Exporters into Hong Kong - Workshop No. 27 (conducted in Cantonese)
• Acoustic Noise of a Medical Equipment
• Minimum label content requirements for each level of packaging (inner, outer, etc)
• Version of Medical device safety standard - IEC 60601
• Packaging validation / qualification report for medical devices - Example wanted
• Customer Supplied Product & Certifications - Drop Ship - FDA and ISO 13485
• Product Release - Final acceptance activities and acceptance records
• Medical Devices Jobs - Abbott is currently hiring
• Format of Device Master Record (DMR) for Combination Products
• Is there a requirement for country of origin on packaging of class 2a medical device?
• Updated MDD "Single Use" definition
• The Status of EN 550 and Whether it will be Replaced Soon by ISO 11135
• Hydrophilic Coating of catheter shafts failing durability
• Upcoming FDA ISO 13485 audit guidance (draft version)
• Risk Management and Manufacturing of Prototype and Test Devices
• Package validation on a different product in an already validated package?
• Measure "TYP" dimensions on a first article inspection (FAI) report?
• Periodic Review of Process and Equipment Validation
• Oxygen gauge on Nitrogen supply
• U.S. – China Joint Commission on Commerce and Trade (JCCT) - Fact Sheet
• Risk management procedure is Mandatory?? (ISO 13485)
• What is Risk Analysis certificate? Class III Medical Sutures
• Tips/Documentation samples required for X-ray Film Processor Installation needed.
• Dealing with Outsourced Processes in a DMR
• Should we perform Equipment final calibration-Operations closing
• ISO 13485 vs. GMP - Is there a difference between ISO 13485 and GMP?
• Cost to obtain ISO 13485 Certification/Registration from Start-up
• Software for Medical Devices and ISO 13485
• Oxygen concentrator hazards
• Medical Electrical Equipment / System Peripherals - IEC 60601-1-3
• Standards used for Medical Device MDD Technical Files
• How to set quality objectives of R&D outsourcing - Examples please
• Non-medical device is in the ISO 13485 audit scope?
• Installation Requirements for Bench Top Device
• Medical Device Suppliers Becoming Certified to ISO 13485
• List of Global Medical Device Nomenclature (GMDN) Codes
• OEM IVD's and CE requirements
• New ERP system Validation
• Identifying Critical Components for Incoming Inspection?
• Medical Device Choke Hazard standard or guidance
• Who should be involved in Management Review?
• Comparison of 21 CFR 820 and ISO 13485
• BS EN980 and Latex symbol
• Manufacturing date on serial number plate?
• Sample MDR and complaints procedure wanted - Medical Devices
• Which supplies/suppliers need to be listed in DMR?
• Mold Material Standard - Material for making molds supporting medical devices
• Cleanroom Gowning Disposable Lab Coats - Class 8 Cleanroom
• GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003
• CE-marked products transport to Non EU countries...
• Successful Validation = Reduced Inspection? No Inspection??
• Software to Manage Compliance to ISO 14971 (Medical Device Risk Management).
• IEC 60601-2-6, Microwave Therapy Equipment
• ISO 13485 for medical device company in US
• Medical Devices Distributor and ISO 13485
• ISO Occurrence Form CG00010196
• IEC 62304:2006 Medical device software - Software life cycle processes - Issued
• Quality System Record as required by CFR 21 Part 820.186.
• Applying AQL when 0 defects are acceptable
• Relevant Packaging Standards for Medical Device Package testing
• Outsourced Manufacturing - Do we or our manufacturer has to perform the validation?
• Training & Competency - ISO 13485 - Question
• Code review as part of software validation
• CAP for Medical Device Class Is product - Slightly confused - ISO 13485
• Organization Structure - Small Company, alotta business
• User Interface Label language Requirements
• Do nonconformances always result in corrective action
• Coming up with initial policies sufficient to get everyone headed on the right track
• Risk Management Plan for Medical Device - ISO 14971
• Is a written procedure required for handling significant change?
• When is the revised standard ISO 13485 going to be released?
• Identifying Inspection Level for Critical Components - Medical Devices
• Internal Audit Check List for Passive Medical Equipment
• IEC/AAMI/ANSI 60601-1:2005 Checklist
• Product Release vs. Pyrogen Test on each Lot - Medical devices
• Product vs. Process Change Control
• Process Approach - Implementing ISO 13485
• Classification of Bio-diagnostic Products as per EU Directives
• ISO 13485:2000, 2003 ...and all certificates for medical devices
• What certifications needed when doing Plastic Parts Manufacturing?
• New intended use - Validation of a class IIb implantable (non-active)
• Medical device facility validation - Need help
• Class 8 100,00 Cleanroom - Airborne Microbial Count
• Administrative personnel training - ISO 13485 and FDA QSR requirements
• Soldering Standard - What is the soldering standard used for medical devices?

vB Easy Archive Final ©2000 - 2009 - Created by Stefan "Xenon" Kaeser