- Bulgaria IFU language - Instruction Translations - CE marked Class III products
- Industry inter-lot variation standard for Enzyme Linked Immuno Sorbent Assay (ELISA)
- Export of Medical Devices to Iran
- Details of Clinical Trials of Medical Devices in China
- Drug Device combinations - Drug degradation and impurities
- Biocompatibility/ISO 10993 training
- CE Marking Technical File questions
- What happened to Part 804? 820.198 (3) references part 803 or 804
- Essential Requirements for Medical Devices - Word copy wanted
- What is Product Realization in ISO 13485
- Airworthiness for Portable Electrical Medical Device
- Medical Device Cleaning Lifecycle test - Developing a Design Verification Spec
- ISO 13485 Clause 4.2.2 Documentation Structure - Quality Manual clarification
- Remanufacturing and Refurbishing of Class 1 Medical Devices - Process Question
- Product audit for using the safety mark (ETL) on label
- Is Product Audit Mandatory as per ISO 13485?
- Who is responsible for auditing the Internal Audit system?
- How to find definitions from ISO 9001 when implementing ISO 13485?
- Removal of Obsolete copies of Controlled Documents
- What are the differences between a design dossier and a regular technical file?
- Suppliers for labels to put on medical device cables
- Does anyone know about ISO 13485:2004?
- Label Nomenclature vs. Label Drawing
- Healthcare Canada vs. FDA - Differences in obtaining approval to sell product
- Is ISO 13485 compulsory - Fabrication of precision metal parts for medical industry?
- Manufacturing Establishment License (China) for Medical Devices
- Effective tools for driving decison making down in the organization
- Qualification of Customer-specified Suppliers
- Sell Class III medical devices to Canada prior to Health Canada Approval
- Canada Medical Device Database like the US FDA's 510(k)
- Marketing Communication Change Control - Identifying best practices
- Format to log complaints per FDA sec. 820.198
- How to prepare preclinical physical testing? Medical device license
- GHTF - Guidance on the Control of Products and Services
- Establishing alert and action limits for clean room bioburden
- How to write Executive Summary for Health Canada medical device applications
- Validating ESD (Electrostatic Discharge) Flooring
- Working from a previous design history. How can I best leverage the exisitng DHF?
- Implementing Dock-to-Stock when regulated by ISO 13485 and 21CFR820
- Should I invest in ISO standards for the CBA (Certified Biomedical Auditor) exam?
- Storage Conditions for Medical Devices
- NetSuite ERP and CRM features Validation for a medical device company
- Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Training
- Can we use the data in intertek or TUV lab testing report as bench testing data?
- Checklist for ISO 11607-2:2006 - Medical Device Packaging - Information needed
- Need copy of GEP guidance
- Format of Stent stability testing (accelerated and long term aging)
- Successful Audit: Thanks for your help!
- Difference between Customer Complaint and Service Call as in ISO 13485
- Multiple Site ISO 13485 Certification
- Obsolete a DoC if NB (Notifying Body) changed
- Animals for biocompatibility testing?
- ISO 13485 implementation - Product realization is done at the 3rd party site
- Biocompatibility of Medical Device
- Who should "own" the Risk Management Process?
- Sterilization validation for reusable medical device class II
- ISO 13485 reassessment audit and passed with no NCs and 2 OFIs
- Design Dossier up to date required - Audit finding - CE Marking
- Interpreting Responsibility and Authority Clause 5.5.1 ISO 13485
- Using Class 3 used Electronic Devices for Training purpose
- Improving 13485 third-party audits - getting your feedback for our training program
- Effectiveness of corrective actions
- Re-Validation criteria and Requirements for Manufacturing equipment on site
- For a PRODUCT DEVELOPMENT ONLY organization, which certification is more appropriate?
- Device restrictions under Health Canada's Special Access Programme
- Audit RESPONSE Training
- Already ISO 9001 Certified - What happens when we get ISO 13485 registered?
- EN 13795 Surgical Drapes and Covers...any other makers of plastic-film drapes...
- Processing time for a Health Canada Class III medical device licence application
- Health Canada - Stability of our device at below freezing temperature (-2 to -8°C)
- System or Method for Classification of Surgical Items
- Language Translation Requirements - Medical software company
- Inputs/Guidance/Information related to ISO 13485 and CE marking
- Both AS9100 and ISO 13485 registered?
- Proving a device is equivalent to another device from literature review.
- Risk Management Information - Contract Manufacturer
- Can a non-medical device manufacturer (mold making) be certified to ISO 13485?
- Standards for Electronic Labeling of Medical Devices
- Good Engineering Practice (GEP) & ASTM E2500
- Project Planning Approval Board Approval signatures - FDA regulated medical device
- Is it necessary to get ISO 13485 certification for Medical Devices?
- CONTAINMENT of affected product - What situation mandates PRODUCT HOLD
- Documentation of the determination that an NCMR is invalid
- ISO 13485 Clause 7.6 Control of Monitoring and measuring devices - Requirements
- Choosing a laboratory for biocompatibility test
- Getting employees motivated to read and follow procedures
- Factory Inspection to Register and Certify a Medical Device in Brazil
- Required documents for Class III Medical Device in Yemen
- Is ISO 9001 necessary if ISO 13485 certified?
- Expert advice on in vitro cytotoxicity test ISO10993-5
- V&V (Verification and Validation) Medical Device Unit Testing
- ANDA Filing - Application for one of our ophthalmic solutions
- Affix CE mark after V&V (Verification and Validation) or after LMR
- Any experience with a plain paper diagnostic printer?
- PQ and PPQ - Process Qualification for medical device manufacturing
- Requirements for Retention of Returned Goods regarding complaints after investigation
- Reference to EN550 or ISO11135 - on an ISO 13485 Certificate
- Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 11137
- Medical Device Clinical Trial Labels
- Limited manufacturing release (LMR) vs. Full manufacturing release (FMR)
- Good Laboratory Practices (GLP) Gap Analysis
- Medical Device Biocompatibility Testing - End product or components - ISO 10993
- Registration - Korea Food and Drug Administration (KFDA)
- Calibration service requirements for device manufacturers - ISO 13485 requirements
- Biocompatibility study necessary? Polycarbonate tip wrench tool
- Mandatory Language Requirements Saudi Arabia
- Do initial importers need a contract with suppliers - Medical Devices
- Rx Only vs. Professional Use Only - Class II private label medical device
- Starting to write a Quality System Manual - Import/export medical devices - Need help
- Calibration interval (Clause 7.6 ISO 13485:2003) - Biomedical test instruments
- Temperature Cycling Process - Continual Improvement and ISO 13485
- Developing an ISO 13485 System - New Small Medical Device Company
- Non-EU countries who use your EC Certificate & Declaration of Conformity
- EA Code 9 (printing) as it relates to 13485
- Distributor Control - Medical Device Manufacturer
- Passed our registration audit - Well we did it!!!!!!!
- Design Input Proposal and Design Control Checklist Formats wanted
- PO (Purchase Order) Clauses - Entry Clause
- USP Class I & II - Raw material supplier liability and responsibility
- Life of a Device being Mandatory on the Packaging - New meddev amendment
- DEHP and BPA containing medical devices attestation form, Health Canada
- Information on Heavy Metal testing in Medical Devices
- Document headers on quality forms that are issued to customers
- No validation for a contract specification and software developer?
- Can a site that does not manufacture or assemble a device be ISO 13485?
- Who should be the person to release product to customer
- Component supplier electrical test requirement - Obsolete Components
- Quality formats - ISO 13485 Design and development related records and formats
- Games people play...needed for basic ISO training
- GMP CFR 820 - ISO 13485 comparison
- Guidance Documents on determining the Life of a Medical Device
- IFU for Canada Class III Medical Device
- Types of Medical Device Cytotoxicity Testing - ISO 10993-5
- What is the difference between regulatory affairs division and patents division
- QA/RA Manager Job Description
- Risk Management for Purchased Devices
- Packaging Validation is Suffocating me - We deliver our products non-sterilized
- Release of Product without Process Validation
- In vitro diagnostic medical devices - Labeling Standards EN 375, EN 591
- Labelling - Country of Origin. Import requirement
- Required Genotoxicity Tests for Implantable Medical medive
- Is a surgeon's marker pen a medical device?
- Defining Customer Requirements - Document that addresses customer requirements
- EU Language Requirement for Repair Manual
- Multimaterial Biocompatibility Question: Materials are all individually biocompatible
- CE Marking: Date of Manufacture or Date of Shipment
- Bacterial Challenge for "Sterile Fluid Pathway" labeled devices
- ISO 10993-5:2009 vs. ISO 10993-5:2003 differences - Cytotoxicity testing
- Adult Diaper & Medical Device requirements
- Medical Device Quality Manual Examples
- ISO 13485 for customer injection molding
- Sending sample devices to foreign countries
- Vendor Control - How do you keep your suppliers accountable
- Monitoring bioburden on clean room gloves
- Medical Device Software - Control of Nonconforming Product and Rework
- Validation of processes for production for Test Equipment
- Validation of transfer materials - Bioburden of items from lab into cleanroom
- Design Validation - How to perform Design Validation?
- Shelf Life for Products in Storage - Medical Device company
- Practical Reasons Behind The ISO 13485/QSR Regulations
- Product Listing (registering medical devices) in Indonesian Market
- MDD Auditor - Professionalism of the MDD auditor
- How do I bring a Class II MD to Canadian retail shelves?
- Rechargeable battery in medical device - Controling and maintaining batteries
- Medical Device registration in Iraq
- Advice and counsel on ISO 13485 Implementation and Certification
- Developing a QMS for biomedical start up company which only does R&D?
- We did it!!!
- ISO 11135:2007 (EtO Sterilization)
- Software Validation - Pointers would be greatly appreciated - Medical Device Mfg
- How clean should the water be needed during extrusion as a cooling agent - Catheters
- TSA (Tryptone Soya AGar) plates for environmental monitoring
- Costs associated with setting up new medical device QMS
- Software Documents in 510(k) submission (Moderate Level Concern)
- TSA (Tryptic Soy Agar) settle plate durations
- Preparation of Documents defining Design Input
- Is it compulsory to print the CE mark on our software & user manual CD-ROM
- Cause Cancer or not? Claims cancer came back after using a medical device
- Medical Device Classification Guidelines for Product Registration in Colombia
- Medical Device Registrations in Europe
- Shelf-Life vs. Lifetime of Medical Laser Device
- Device shows an Error message - Malfunction or not?
- New regulation for medical devices registration in China
- Cleaning procedure for cleanrooms
- Translation SOP - Labeling and IFU translation
- Process Validation procedure for ISO 13485
- Annual Product Review of Medical Devices
- Crucial Personnel Resignation and Transfer of Responsibilities (medical device)
- ISO13485 Cl. 7.1 Process Flow (product realization & risk management requirements)?
- Quality tasks for each Design Control Phase
- FDA's Unique Device Identification, New Regulations - Pending March of 2010
- GD210 Annex A in excel format?
- Becoming a medical device OEM - Already have ISO 13485 & ISO 9001
- Follow-up audit after safety mark authorization (Medical device)
- Can "7.5.1.2 cleanliness of product and contamination control" be non-applicable?
- CMDCAS Checklist with the additional requirements for Health Canada
- Writing Test Procedures for Medical Devices
- Passivation of Medical Devices
- Medical Device Guidelines - India
- What certification is Required to Sell medical devices in the UK
- Repairs vs. ISO 13485:2003 Section 7.5.1.2.3 Servicing
- Interpreting clause 7.5.2.1 (validation of software used in production & service)
- CNC Machine Operational Qualification Recoverability Testing
- How long must I provide service or spare parts for medical devices
- Free Trade Certificate - Planning to sell our products to some foreign countries
- Looking for an ISO 13485 & 21 CFR 820 Pocket Guide
- Does overdue preventive maintenance require an evaluation on product quality?
- Dental handpiece with product code EFB for 510k submission
- CAPA Software with Oracle integration capabilities
- ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices
- Medical Device Packaging - Trying to learn Technical files
- Medical Device Software - User Interface Language - 93/42 CE
- Certification Body Standard Agreement Term - 3 Years? Can I then change CBs?
- Medical Device Regulations - Importing to Singapore - Orthodontic brackets
- Changing a Class II product's name after/during regulatory approval
- Revision date for SOP (Standard Operating Procedures)
- GHTF definition of Manufacturer, Authorized Representative, Distributor and Importer
- Differences between Australian & EU Medical device regulatory requirements
- Does anybody know about EN45014? (Replaced by ISO/IEC 17050-1)
- Marketing Prototype Devices - Waiting for 510K approval on implant (mesh) device
- Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
- Does anyone have experience using open source software for PDM?
- The process for Canadian Marketing of Class II, III, and IV Medical Device
- Intended Use vs. Intended Purpose vs. Intended by the Manufacturer - Doubts
- Pest Control procedure for a manufacturing facility.
- Limulus Amebocyte Lysate (LAL) Testing: A necessity on every lot?
- Medical Device Registration Process in Russia
- Conformance Audit Template/Help - Audit of my QMS to the ISO standard
- No-No List of raw materials in medical devices?
- Medical Device Releasing - Guideline and who is held accountable
- Complaints & CAPA's (Corrective Action Preventive Action) for Clinical Trials
- Good Distribution Practices - Medical devices
- EU - Does the MD label have to be harmonised?
- Could we combine ISO 13485 and ISO 9001:2008?
- Help for implementing ISO 13485 (provision of software to Hospitals)
- Risk Assessment of Raw Materials? Medical Device product
- Risk Management for Contract Manufacturers
- Class I Medical Device with measuring function: Involvement of NB etc
- Subcontracting and Control Issues - Class I Medical Devices with Measuring Function
- ISO 13485:2003 / Corrigendum 1:2009 has been published - Free!
- Customers assessed as Suppliers - Sub-Contractor request
- Medical Device Advisory Notice Procedure
- PFMEA RPN rankings - Preventative action must be opened if RPN over 100
- Medical Device Stability Testing
- Acceptable Fatigue Safety Factor for Testing Medical Device
- Traceability SOP Audit Finding - Does not describe the extent of the traceability
- Addition of a Class 1 (Sterile) Medical Device
- CAPA - What criteria should be used to initiate CAPA's ?
- Radiopacity Testing Laboratory suggestions
- Biocompatibility 10993-1 vs. Sterilization Cycle - Medical Device in EU
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