- Control Over Outsourced Processes - Share some experiences and methods
- When Validation Needed? We are changing to new process equipments
- Official Government Regulatory Body Vigilance Contacts to use for China and for India
- Which ISO Standard is relevant for Refurbished Medical Devices?
- Incoming Inspection Sampling Plan ISO 2859-1/ ISO 2859-2
- Technical Agreement for Suppliers ??
- Safety Standards for Gastro and Urological Catheters
- ISO13485 application: can subcomponents or non-medical products be excluded?
- Documented Rework Procedure - ISO 13485 Requirements
- Raw Material Specifications - Medical Device Company
- List of Global Medical Device Nomenclature (GMDN) Codes
- IQ, OQ & PQ (Installation, Operation, and Performance Qualifications) on a CMM
- Identifying Critical Components for Incoming Inspection?
- Advice on Outsourcing all Manufacturing, Warehousing and Distribution Processes
- Validation of Commercial off-the-shelf software - Spreadsheets
- 21 CFR 820.70 (c) Environmental Control and Pest Control
- Continuing Assessment Audit - Recommended for continued registration 13485:2003
- Biocompatibilty Testing - National Test Centre (NTC), China
- Distributor Requirements - Vigilance and Traceability
- Sterilization Dose Audit - Recommended Quantity of Samples/Batches
- Recommended for Certification - R&D only (without Manufacturing or Marketing)!
- Titles for Quality Functions - Very small business quality department query
- Auditing External Suppliers of Finished Devices
- Israeli Medical Devices
- KPIs (Key Performance Indicators) and Risk Management Process (ISO14971:2007)
- List of regulatory steps to obtain market clearance in different countries
- GMDN Codes for 'High Frequency Radiosurgical systems'
- Start Up Medical Device Company - As a device company what FDA cert do we need?
- Is Site Master File necessary for a European Medical Device Manufacturer (class III)?
- Medical Device Manufacturer: Incoming Raw Material Inspection
- Sterility Assurance Level of Liquids (SAL) - Special Culture Medium
- How long must we provide support for medical software
- 60601 Symbol Issue - CE Mark Symbol and Size Requirements
- Ideas for a Regulatory Careers presentation?
- ISO-13485 and ISO-9001 - Medical Device Company - Distributor wants ISO9001
- Has ISO 13485: 2003 been Updated?
- Review and Implementation of Customer Requirements
- Component Specifications - Difficult to get Component Specifications from Customers
- STED vs. CE /FDA etc - Seeking advice
- Contract Manufacturer - Technical/Device Master File Responsibility
- Incorporating Risk Management into CAPA
- Management Review output - privileged or audit fodder?
- Sample Retention Requirements - Quality Records procedure - ISO13485
- Validation Requirements - ISO 13485 / MDD Technical File
- Current Medical Device under 9001 Excluded from future ISO 13485
- Material Non-conformance per 21 CFR part 820: Subpart I - Medical Devices
- MDD Essential Requirements Checklist - Complete?
- How to practically organize the 'Vigilance' function?
- Surgical Sutures and Absorption - Break strength retention (BSR) properties
- Polypropylene Sterilization with Heat Autoclave
- Dual Quality Systems? Pharmaceuticals and Medical Devices
- Is testing per ISO 10993 - 5 required for resin discoloration ?
- Approved Job Descriptions under Revision Control - Required?
- Documentation for Returned Contaminated Medical Devices
- Releasing documents you are not in compliance with
- Cl 7.2.1c Statutory and Regulatory Requirements Related to the Product
- Question regarding supplier approvals
- Biocompatibility testing & Registration in China
- Health Canada Registration - New Class II Medical Device
- Need step-by-step ISO 13485 implementation help
- Documentation for Health & Safety (OSHA) require ECO's?
- Comparison of 21 CFR 820 and ISO 13485
- Risk Assessment according to ISO 14971 - Medical Device Software
- Sterile Pouch Peel Force of 1 pound/inch width
- OEM IVD's and CE requirements
- Risk Analysis Requirements - Medical Devices Manufactured prior to 1998
- What is a reasonable Bioburden limit?
- Is Risk analysis for plastic parts of medical devices required?
- Established procedure for Advisory Notices - ISO 13485
- Shipping Validations prior to exporting our product
- Is spray painting allowed for non-blood contact medical devices?
- EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices
- EU Vigilance - Internal Forms
- Upgrade to NC Database - Root Cause Category Listing
- Mark on Medical device label marketed in Canada
- CSA Requirements - CMDCAS - ISO 13485 - Medical Xray camera for Canada
- GHTF - Study Group 1 (SG1) - Final Documents issued
- Who is responsible of Advisory notices
- Requirements to market/sell existing medical device in EU, Canada
- Gamma Sterility Validation - ISO 11137-2, 4.2 vs. FDA Requirements
- 1. Hardware Life Cycle; 2. Requirements tracking; 3. FMEA Risk Analysis
- Class 2a Medical Device (Nebulizer) - What is best route to getting CE mark?
- Health Canada : Requirement for Inter-dependent Medical Devices
- ISO 10993 - Required Testing - Can I follow the literature route?
- Can I perform an ISO 13485 audit? I'm a registered RABQSA QMS and AS9100 Auditor
- Product Storage Specifications
- Iran - Medical Devices Regulations - Homologation
- Startup Medical Device Manufacturing Company Guidance
- Contract Manufacturing of Medical Device
- Ethernet port connections to meet 60601-1 and 60601-1-2
- Support for Obsolete Medical Devices
- Signature on Management Review Minutes - Quality Records
- Lean SCAR Process and Form needed - ISO 13485 and FDA
- Global Medical Device Requirements
- EtO Sterilization - DIN/EN 550 - ISO 11135
- Correct Label Symbol to be used for Steam Sterilisation
- QC Testing - Repeat test sample numbers
- Starting fresh with ISO 13485:2003 certification
- Affordable electronic CAPA system (compliant to FDA 21 CFR Part 11)
- Are batteries in a Medical Device, also considered a MD?
- Medical device facility validation - Need help
- Medical Device Registration requirements for Algeria and Libya
- Batch / Lot Numbering - Sterilization
- Are Sales allowed Under an expired CE Certificate?
- Label placed on medical device by subcontractor based outside USA
- How to practically-conduct, post production phase
- Question: outsource medical device electric safety test to OEM supplier
- What Constitutes "Manufacturers Claims" about a product?
- Anyone having ppt file on Advisory Notices ?
- DHR and components under deviation - Medical Devices
- Changes to Component Specification & Manufacturing Site
- Pre-packaged quality systems - Class IIa Medical Device
- Do nonconformances always result in corrective action
- Custom prototype checklist for Europe and FDA
- Technical File vs. Design Dossier? Class II and Class III Medical Devices
- Product Release vs. Pyrogen Test on each Lot - Medical devices
- ISO 14971: Perceived or alleged risk?
- Validation of bone screw manufacturing process
- Code review as part of software validation
- Upcoming FDA ISO 13485 audit guidance (draft version)
- Bioburden tests duration and Monitoring of gloves
- Essential Requirements - Example of the essential requirements filled in
- Soldering Standard - What is the soldering standard used for medical devices?
- User Interface Label language Requirements
- Classification of Bio-diagnostic Products as per EU Directives
- Internal Audit Check List for Passive Medical Equipment
- Administrative personnel training - ISO 13485 and FDA QSR requirements
- Class 8 100,00 Cleanroom - Airborne Microbial Count
- Process Approach - Implementing ISO 13485
- New intended use - Validation of a class IIb implantable (non-active)
- What certifications needed when doing Plastic Parts Manufacturing?
- ISO 13485:2000, 2003 ...and all certificates for medical devices
- Product vs. Process Change Control
- Cleaning standards for Medical Devices - Implants - Cleaning Validation
- Identifying Inspection Level for Critical Components - Medical Devices
- When is the revised standard ISO 13485 going to be released?
- Medical Electrical Equipment / System Peripherals - IEC 60601-1-3
- Risk Management Plan for Medical Device - ISO 14971
- Coming up with initial policies sufficient to get everyone headed on the right track
- CAP for Medical Device Class Is product - Slightly confused - ISO 13485
- Organization Structure - Small Company, alotta business
- Does anyone have a Cleanroom audit checklist?
- Outsourced Manufacturing - Do we or our manufacturer has to perform the validation?
- Manufacturing date on serial number plate?
- Successful Validation = Reduced Inspection? No Inspection??
- Relevant Packaging Standards for Medical Device Package testing
- Contradictions in the reporting timelines of IVD Directive and MEDDEV 2.12-1 Rev 5
- Training & Competency - ISO 13485 - Question
- Applying AQL when 0 defects are acceptable
- ISO Occurrence Form CG00010196
- Oxygen concentrator hazards
- ISO 13485 for medical device company in US
- Standards used for Medical Device MDD Technical Files
- IEC 60601-2-6, Microwave Therapy Equipment
- Cleanroom Gowning Disposable Lab Coats - Class 8 Cleanroom
- CE-marked products transport to Non EU countries...
- Which supplies/suppliers need to be listed in DMR?
- GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003
- BS EN980 and Latex symbol
- Who should be involved in Management Review?
- Medical Device Choke Hazard standard or guidance
- Non-medical device is in the ISO 13485 audit scope?
- New ERP system Validation
- Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfaction
- Integrated CAPA database for internal audit and nonconforming material
- Medical Device Suppliers Becoming Certified to ISO 13485
- Package validation on a different product in an already validated package?
- Installation Requirements for Bench Top Device
- ISO 13485 vs. GMP - Is there a difference between ISO 13485 and GMP?
- How to set quality objectives of R&D outsourcing - Examples please
- Software for Medical Devices and ISO 13485
- Measure "TYP" dimensions on a first article inspection (FAI) report?
- Dealing with Outsourced Processes in a DMR
- Cost to obtain ISO 13485 Certification/Registration from Start-up
- Any experience with Clinivation??
- Should we perform Equipment final calibration-Operations closing
- Tips/Documentation samples required for X-ray Film Processor Installation needed.
- What is Risk Analysis certificate? Class III Medical Sutures
- Please help me to convert from ISO9001 to ISO13485
- U.S. – China Joint Commission on Commerce and Trade (JCCT) - Fact Sheet
- Risk management procedure is Mandatory?? (ISO 13485)
- Oxygen gauge on Nitrogen supply
- Periodic Review of Process and Equipment Validation
- Risk Management and Manufacturing of Prototype and Test Devices
- Customer Supplied Product & Certifications - Drop Ship - FDA and ISO 13485
- Hydrophilic Coating of catheter shafts failing durability
- Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements
- CE Marking Basics - Laser - I am new to Regulatory
- Updated MDD "Single Use" definition
- ISO 13485 Risk Management for Contract Manufacturer
- Minimum label content requirements for each level of packaging (inner, outer, etc)
- Is there a requirement for country of origin on packaging of class 2a medical device?
- Version of Medical device safety standard - IEC 60601
- Medical Device and Importation Requirements for Tradeshows in EU
- Product Release - Final acceptance activities and acceptance records
- Medical Devices Jobs - Abbott is currently hiring
- In-Process Non-Conformance Report Contents
- Packaging validation / qualification report for medical devices - Example wanted
- Approved Supplier List ISO 13485
- Acoustic Noise of a Medical Equipment
- Medical Device Exporters into Hong Kong - Workshop No. 27 (conducted in Cantonese)
- MDD Classification - Marketer Has Misclassified A Product?
- Changes to QRI (Quick Reference Instruction)? What I can or cannot change
- Gulf Cooperation Council (GCC) Common Market for Medical Devices?
- Turkish factory under US umbrella - Small medical device manufacturer
- Does EN 60601-1 include 60601-1-2 from a contract point of view
- BioHazard Cleaning of Returned Devices - Small Medical Device company - Need Ideas
- Ownership of ISO 13485:2003 company changing - Anyone to update?
- Repairs vs. Scrapping for Parts and Serial Numbers
- IEC 62304 compliance status - Is it mandatory for 510(k) submittal?
- Asian Harmonization Working Party to hold meeting on Nov 5, 6 in Delhi
- Effectiveness of Supplier Corrective Actions
- Is a Test or Prototype Implant a Medical Device per ISO 13485 definition?
- The air kerma measuring device - Does anyone know anything about it?
- JMDN (Japanese Medical Device Nomenclature) codes list needed
- ISO 13485 IAF Medical Device Conformity Assessment System IAF-MDCAS
- ETO Sterilization - Process monitoring and out-inspection
- Suitable Sterilization Cycle to achieve Sterility Assurance Level of <10-6
- External Document Control Procedure advice wanted
- Keep current ISO 13485 registrar AND add new for CMDCAS
- Tough Decision - Not a medical device anywhere except US and Canada
- Clean Room - Standards or some type of Clean Room Validation - ISO 13485
- Filing of Registration Documents in an organised or consistent way
- X-ray's light testing - What is the standard to test the X-ray light brightness?
- New Directive Outlined for Medical Devices by ASEAN
- USB Port Isolation as per IEC60601-1 - Medical Device
- Medical device with NON medical PC - USB galvanic insulation
- GMP Stores qualification/validation plan or protocol - New Store requirements
- ISO 13485 implementation - Other required standards and guides
- FDA Regulation Training Materials
- Supplier Quality vs. Supplied Material Quality
- I will be an ISO 13485 Auditor soon - Your suggestions are appreciated
- Registration/Homologation Colombia & Cuba - Class I and IIa medical devices
- CLIA vs. QSR Audit Differences - and - Audit templates for CLIA audits
- Device Master Record requirements - wrong approach?
- Could We use electronic signatures rather than manual sign offs?
- Are artificial teeth medical devices? If so, which class do they belong to?
- Medical device registration process in Brazil - Anvisa
- Guidelines that specify the frequency of ETO Sterilizer Re-Validation
- Italian Device Classification - CND
- Utility - Electrical operation qualification protocol for validation
- Biocompatibility testing centre in Montreal QC ?
- Best Risk Analysis Approach (ISO 14971) - Class IIa medical devices
- Protocol to validate the use of Electronic Records like DHRs, NCMRs, Validations
- Appropriate FMECA handling of cascading failures?
- Risk of fire in an Oxygen rich environment - Fire Prevention - IEC 60601-1
- The key differences between EN 46001 and ISO 13485
- ISO 13485 and network security protection - Medical device manufacturer
- CMDCAS (Canadian Medical Devices Conformity Assessment System) for drugs
- Medical Device Adhesive with USP class VI, suited for oral 'use'
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