- 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
- 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
- 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
- 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
- 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?
- 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
- 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
- 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?
- 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
- 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
- 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
- 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 ?
- Protocol to validate the use of Electronic Records like DHRs, NCMRs, Validations
- Appropriate FMECA handling of cascading failures?
- 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'
- Production and Service Provision - AS9100 vs. ISO 13485 - Numbering Issues
- How to Audit Outsource process (New Trainee Auditor)
- Official Languages of the European Community
- Polyester Biocompatibility standards - Anyone here have any experience?
- Need Advice: Regulatory Requirements Audits
- Procedure for Recall of Medical Devices - Where?
- Statistical Process Control (SPC) for Clean Room Environments
- Supplier Control: Medical software "module"
- ISO 13485 Audit requirements - Manufacturing requirements in draft?
- Supplier name on label of IVD packaging
- SOP's (Standard Operating Procedures) - the "write/right" way
- Process Interaction Map for ISO 13485
- 510(k) filing for GSM (Global System for Mobile Communication) technology?
- Luer taper tolerances - 6% or otherwise - Dimensional accuracy
- Biocompatibility - Hospital Bed
- UMDNS of air compressor nebulizer
- Defining Product Lifetime - Medical Devices
- Distributor Requirements for Sterile Disposable Medical Devices
- Implementing Change Control on Company Website
- How to sell Veterinary Devices to Canada
- Veterinary device is medical device or not?
- MDD Class III Exclusions
- What are the next steps for a medical device entering Canada?
- Uneasiness regarding medical device responsibility... Multi-company activity chains
- Recall or advisory notice sufficient for software
- Particle Counter Results - Interpreting Data for a Class 100,000 Cleanroom
- How to confirm the class of medical device is correct?
- Implementation period for standards - CE renewal submission - Class II medical device
- Japan Medical Devices Regulations
- CE Marking Medical Device with Software - together or separate?
- Justification/Rationale for not investigating a nonconformance
- Korean requirements for foreign medical device contract manufacturers?
- Medical Device Registration(India) and Power of Attorney attestation clarification!
- Requirements for Marketing a Medical Device in India
- "Calibration Not Required" label requirements
- Documents of External Origin - Periodic or annual verification of revision status
- Device Identification Number (DIN) - Canadian License for Medical Devices
- Upgrading of QMS from ISO 9001 to ISO 13485 - Quality Manual Revision
- CNC Machine Validation Requirement
- IQ, OQ, PQ (installation, operational & performance qualification) compared to PPAP
- Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants
- Cleaning Validation Protocol in a Cosmetic company
- Kit Certification for 510(k)s on the CDRH website - Does anyone make these?
- SFDA Approval (China) - Changing Locations
- Which standard is applicable for IR LED in conjunction with medical devices?
- Supplier Evaluation and Approval of a Translation company
- Requirement of GCP for a clinical trial of IVD
- Risks related Wire & Cable for Electronic Medical device - Risk Management
- Design for Sterilization Companies - The design of sterilization validation programs
- How do you Control your Spare Parts?
- Question about biocompatiblity of medical device - Contacts with patient skin
- What's the relationship between LVD (low voltage directive) and MDD
- Blasting Visual Standard Validation - Site Acceptance Test required
- Question Stainless Steel grade required for Medical Devices
- Australia - The process to declare conformity for a class IIa medical device?
- Spare Parts for Medical Devices
- Rechargeable NiMH Battery Life in Medical Devices - Replacement Intervals
- Who signs your Declaration of Conformity?
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