- Selling Class IIa medical device (sterile syringes) in USA
- Are "Controlled Rooms" or "White Rooms" referred as ISO Class 9 rooms?
- Looking for Case Studies for How to interpret the requirements of ISO 13485
- Risk Analysis using Fault Tree Analysis (FTA) or Hazard Operations Analysis (HAZOP)
- Medical Device Kit Components and Labeling
- Setting up a laboratory for a manfacturer shut down by FDA
- Silly question..."elements of the standard" or "clauses of the standard"?
- When should the medical device industry show compliance to EN ISO 14971(2007)
- Where I can pursue Quality related training near New York City?
- Medical Device QC Testing - Number of Samples as Batch Size Increases
- Corrective Actions needed for Registration Audit Nonconformances
- Data Capture under FDA QSR21 CFR 820.70 G
- Should I be notifying the FDA of adverse effects (per 21 CFR 803)?
- Cosmetics - List of Banned ingredients in the US
- FWD: Your review of 13485:2003 & 14969:2004
- Label Shelf Life shorter than Product Shelf Life
- FDA expectation of Concessions - Changes to a DMR
- Regulatory Contacts in every country for Medical Device Vigilance purposes
- Inspection Parts as saleable goods - IS0 13485 OEM medical device manufacturer
- Validation protocol for a crimped contact on a stranded wire
- Calculating Basic Risk/ Basic on Risk Analysis - Medical device MDD Class II and up
- "Indication for Use" used in 510(k) - Indications for use vs. Intended use
- FDA Medical Device Audit Checklist.
- Advice or accepted standard for lot numbering - ISO 13485
- Excessive temperature testing to IEC 60601-2-37 - Internal Probes
- In the following statement, what does "Z" stand for?
- What is a Purchasing "Advisory"?
- Training myself on my own SOP (Standard Operating Procedure)
- Internal Auditing - ISO 9001 auditing vs. FDA CFR auditing - Which to choose?
- Record retention ideas for a sheet metal job shop supplying to a medical device mfg.
- Biocompatability (ISO 10993 Series) Testing for Infusion Systems
- Validation master plan - Existing cleanroom facility that will be upgraded
- Medical Device Software Risk Management and ISO 14971:2007
- ISO13485 Special Requirement - Paper used for plotting charts
- Standard(s) used to Test Sterile Ultrasound Gel for use on Heart
- Supplier Quality Agreement that one of our customers has sent us?
- Class IIa Medical Device and Subcontracting questions
- Medical Devices Manufacturing Cleanroom Protocol and Subcontractor
- More on Biocompatible Ultrasound Gel
- Approval list for mechanical and electronics drawings in a Medical Device company
- Work Instruction or Checklist for Inspection Instructions?
- Product Identification & Traceability (when a part number changes)
- ETO Product Sterilisation Testing Standard
- Retention Sample Requirements ISO 13485 and 21 CFR Part 820
- Internal Auditor - What is required to have someone qualified as an internal auditor?
- Validation of Sterilization Expiry Date - Accelerated Aging, etc
- What do "OAI" "VAI" and "NAI" used in FDA QSIT manual mean in inspections?
- How to do Equipment Validation - Establishing our ISO 13485 QMS procedures
- QC Visual Standard for Medical Product
- Submission of 510(k) - Does the FDA require a predefined structure of the content?
- What Marketing/Market Penetration information should go on the DMR?
- Medical Device DMR's - List of the Marketing or Market Penetration documents
- Directives and regulations required for medical implants with RFID sensors
- FDA-Listed/Registered "Manufacturer" also a contract manufacturer?
- Vendor-sub-part MD documentation
- Involvment of IRB (Institutional Review Board)
- Annual Safety Test for Electrical Medical Equipment
- Medical Gases Installation - Can be classified as MD and ISO 13485 certificated?
- Where to begin - creating a Quality Plan for Class I Medical Device
- Medical Devices Distributor and ISO 13485
- Usability standard IEC 60601-1-6 in the Medical Device Industry
- Medical device (sonic scaler): experience with 84/539/EEC Directive
- Component Traceability for a Class 2 Electronic Medical Device
- DMR/DHF/DHR/Batch Records/Master Batch Records
- Validation Report - IQ, OQ, PQ and Reports for Injection Moulding and/or Sealers
- ISO 13485 Quality Manual Requirement
- Dissemination of MSDS regarding your product in your company?
- Orthopeadic products Sterilization Location (bone screw, plates, bolts, etc.)
- Relevant Standards for Product Standard, Testing, Specification Measurement, etc.
- Which documents in the DHF (Design History File) should be controlled?
- Complaint Closure - Auditing the Complaint Department
- Manufacturer Obligation to Declare the Lifetime of its Medical Device?
- QSR Sections for a Medical Device - Seven questions
- Percentage of Class I Medical Devices in market - viz Class I, Class II and Class III
- Need information about the Medical Devices Reimbursement in UK
- I want to send a CAPA to a supplier...
- 2005/50/EEC Reclassification
- X-Ray Films - CE-Mark and Related Standards Requirements
- Impact of CE Marking on ISO 13485 Registration
- Cleanliness of Manufacturing Area for Orthopedic Devices and Implants
- Document that summarizes the ISO 13485 and based on ISO 14969
- Re-manufactured vs. Refurbished under FDA QSR
- Research in Mexico, anyone? US class I (non exempt) 510(K) Dental
- Dummy Recall Guidelines - How to evaluate recall effectiveness
- Non-sterile device - Rapid Test Kits - ISO 14644 Clean Room required?
- Health of Employees in Work Environment - ISO 13485, Section 6.4(a)
- MDS 2... who provides this information?
- MDD (European Medical Device Directive) requires subset of ISO 13485
- Flammability of medical textile - any relevant standards?
- Interim Stages of Medical Device Manufacturing Production
- UL First to Offer ISO 14971 Registration Service
- Conduct Mock Recall on Medical Device Product
- Prices of Medical Devices on the global scale
- Sterile Barrier System (SBS) Testing
- MEDDEV 2.12-1 rev. 5 released
- Website that lists Certified ISO13485 Registrars
- Venezuela government is asking for "GMP Certification" - Huh?
- ISO 13485 definition of Medical Device - "Material" or "Article"
- Looking for an accredited FDA MED-DEV 3rd Party Auditor
- Re: How to set Quality Objectives for our Quality Management System?
- Software development company for Medical Device Diagnostic Equipment
- Scope for ISO 13485 vs. ISO 15378 - Molding Parts for Medical Devices
- EC Official Journal Harmonized Standards - Additional requirements?
- ISO 13485 certification for subsidiaries ?
- ISO 15378 certification - Has anyone experience with ISO 15378?
- Should service representatives record the diagnostic equipment information?
- Clinical Trials of Medical Devices in China - Ethics Commision
- Cleaning Protocol Validation - Do we also have to specify the level of cleaning?
- Failure Analysis on our Manufactured Goods
- Comparison of ISO 13485, FDA and JGMP
- ISO 13485 Crossword Handout
- ISO 13485 Nonconformance Identification Exercise
- IVD Manafucturer in India - What Regulatory Requirements to Comply?
- Private Label CE Marked Products for One Person Company
- ISO 13485 Certification for Future Business
- Class III Medical Device with CE Mark Approval - India Registration Process
- Revision of MDD 93/42/EEC, AIMD 90/385/EEC and BPD 98/8/EC published: 2007/47/EC
- Looking for a good ISO 14971 checklist
- Defining the lifetime of medical devices - long lasting parts such as bone screws.
- Poor control of testing chemicals – which ISO 13485/9001 clause does it contravene?
- Is Intracutaneous reactivity test(ISO 10993)the same as intracutaneous toxicity(USP)
- Long Term vs. Accelerated Life Testing FDA Requirements
- Is Bacteriological Monitoring required in ISO Class 8 Cleanrooms ?
- Obtaining / Generating a Global Medical Device Nomenclature Classification
- Introduction of Compulsory Bar Coding of Medical Devices in the US?
- ISO 10993 Tests of End Product vs. Test of Material - Japanese Requirements
- Can anyone help me with ISO 14644?
- MDD 93/42/EEC consolidated version 2007
- How to Ensure DNA Free parts - Molded Parts for Labware
- 60601-2-2 Section 50.2 Accuracy of Controls and Instruments - Help needed
- Return Goods Policy to Provide to Our Distributors
- Obsolete Document Retention Requirements
- Medical Device Regulations for CIS Countries
- Medical Device Regulations for Manufacture and Sale within India
- Detergents for Washer-Thermal Disinfector of Plastic Materials
- Language Requirement for Individual EU & EFTA countries
- The Status of EN 550 and Whether it will be Replaced Soon by ISO 11135
- Control of Nonconforming Product - Customer and/or Regulatory Approval
- User Manual and Label Language Requirements
- Opinion of GMP/ISO Quality Audit Manual for Healthcare Manufac...Leonard Steinborn
- ISO 13485:2003 Clause 1.3 - Applicable Standards and Regulations
- Supplier and Customer Survey (including Logs) Ideas and Examples wanted
- Quality Plan for Gene Sequencing Operation
- My iPod, My Cell, My Insulin Pump - Advances of Diabetics Management
- Canadian Medical Device License Requirements - What if we failed to meet it?
- Is Post Packaging Testing an Inspection of the Packaging?
- Third Party Developed Software as Part of a Medical Device
- Quality System Record as required by CFR 21 Part 820.186.
- Interpretation of ISO 13485 Clause 8.4 - Analysis of Data
- How can I Establish a New Medical Device Laboratory?
- Looking for USA Medical Device Contract Manufacturer - Suggestions?
- Any examples of National or Regional Regulations referred to in ISO 13485?
- CMDCAS Certification Requirements and Audit Preparation
- Could anybody suggest a routemap for CE marking for invitrodiagnostic medical device?
- Where to start with ISO 13485 and Registrars near Seattle
- Guidance on ISO 13485 Section 7.5.2. about Software Validation
- GHTF (Global Harmonisation Task Force) - Guidelines for Regulatory Auditing
- Classification of filtration device to separate epithelial cells, diagnosis of Cancer
- Required Environmental Controls for a Part Provided Sterile?
- Suggestions for FDA compliant QA procedure for invitrodiagnostic device?
- Software Requirements - Need SRS tools like Telelogic Doors and ARTS by Goda
- Is a company required to report management changes to its notified body?
- Audit Checklist for Contract Gamma and ETO Sterilization needed
- EU Representative Contact Address question
- Medical Device Software Compliance - Looking for parties to review and audit.
- Which Fringe Suppliers to Include in the Approved Supplier List?
- Evaluation of Medical Device Suppliers - Categories when Initially Evaluated
- Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (a)
- First Surveillance Audit - QMS Dynamics and Quality System Indicators
- Help with an Unknown 'Swirling' Symbol
- Perfect Selling Fully Functioning Class 1 Medical Device vs. Antique
- MEDDEV 2.12-1 Rev 5 Reportability Decision Tree? Vigilance Reporting Procedure
- What to do to keep ISO 13485 cert when medical device is not produced anymore?
- Requirements for Implantation Records/Cards - Class III, Implantable (not active)
- ISO 13485 Risk Management in Simple Terms
- Italian CEI 62.5 Compliance - Any idea if it's the equivalent of EN 60601?
- When is ISO 13485:2003 Scheduled for Revision?
- Mexican Requirements for IVD Medical Devices
- Justifying Subcontractor (with no QMS) Service - Class 1 Medical Instruments
- Where to find the Medical Device Classification Database
- Comparison between ISO13485 and 93/42/EEC Medical Device Directive
- What to do if we take over an MDD certified company and rebrand product?
- Requirements for Clinical Trials worldwide
- Internal Audit Procedure Change from documentation to implementation...Help!
- Customer Related Processes and Requirements - ISO 13485 Clauses 7.2.1 and 7.2.2
- What are Production/Inspection CP Checks - Class I medical devices
- New Medical Device - Ortho Implant ISO13485?
- Shipping International Samples - Regulations?
- Summary Technical Document (STED) and OEM Technical data
- Health Canada Registration - Cost and related questions.
- United Arab Emirates (UAE) Medical Device Requirements?
- Does ISO 13485 have any Trainer Requirements
- Average Cost of ISO 13485 Registration in US
- Questions about upgrading from ISO 9001 to ISO 13485 or do I have both?
- Should Quality System scope cover non-medical devices?
- James Sorenson (World-Renowned Medical Device Inventor) passes away.
- What is the Minimum Documentation Required for Medical Device Industry?
- Essential Requirements Of A Technical File - ISO13485 / Health Canada / MDD
- We are being recommended for ISO 13485 Certification
- Audit NonConformance - Evidence of Post Market Vigilance and Product Recall.
- ISO 10993 Compliance - Where to start? Class I Medical Device
- Advisory Notice Requirements & Procedure and Form examples
- 93-42-EEC Consolidated Version Published
- Auditor training - Is there a big difference between auditing ISO 13485 & ISO 9001?
- Guidance documents on how to manage a Recall as well as on limits of rework?
- USB Port (Signal I/O) Isolation as per IEC60601-1 - Medical Device
- We were Recently Audited (ISO 13485 & Related) - With 3 Minors!
- Introduction of EN 62304 - Life Cycle Requirements for Medical Device Software.
- EN ISO 13485 Amended by: Corrigendum No. 1 January 2008.
- Software to Manage Compliance to ISO 14971 (Medical Device Risk Management).
- ISO 13485 Certification - No Sterilization, Packing nor Direct Shipping to End User.
- MDD Classification of Software which Supports Physicians - Premie Nutrician
- ISO 13485, Canadian MDR and FDA 21CFR820
- Level of Technical Detail of Technical File Submission
- Expected Service Life of Medical Devices
- Approved for Medical Device Labeling - Medical Requirements for Printer
- Guidance in Performing a 13485 Gap Analysis
- IVD Device - ISO 13485 and Testing for Environmental Operation Specifications
- ISO 13485 Implementation - Medical Equipment Manufacturer
- Bone Wax Sterilization Requirements - Medical Device
- TOP 15, FCT, FCTR - What do TOP 15, FCT, and FCTR stand for
- Record Retention by R&D Shop After Handover
- Documented Procedure in Quality Manual
- Approved Supplier List - R & D, Capital Equipment
- Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance
- Cleaning and Sterilization - ISO 13485 sections 6.4 and 7.5.1.2.1
- Italian Ministry of Health Medical Device Databank regulation
- Differences in Manufacturing of Class I, II and III Medical Devices
- Components Cleaning for Manufacturing Sterilized Medical Device
- Retrospective Medical Device Certification
- Life Cycle - ISO 14971:2007 meets ISO 14630:08
- Medical Device Manufacturer REQUIREMENT is compliance with 93/42/EEC
- Standard Medical Device (Health) Icons?
- FDA acceptance of Guidelines vs Procedures
- QA/RA Function in Medical Device Industry
- ISO13485:2003 Documentation – Reference Table
- ISO 13485 and IQ (Installation Qualification), OQ (Operational Qualification)
- Any standards for fabrics & materials in medical devices
- Change Control Form - Approval process for cross departmental communication
- How to handle medical product changes? - Japanese market
- Looking for an FDA MDR/Incident Report Decision Tree
- Clinical Evidence and Expert Evaluation
- Prescription Devices and OTC Devices Labeling differences
- India - Drugs Master File Notarisation for UK based Manufacturer
- Refer FDA Brochure - Home Healthcare Medical Devices : A Checklist
- Expiry Date of Sutures based on Shelf Life of Raw Materials
- Biocompatibility Testing for Implantable Medical Devices according to ISO 10993
- Where do you address Stock Recovery? In your corrections and removal procedure?
- Does ISO 13485 certification require a company to follow 21 CFR Part 820?
- Own Brand Labelling (OBL) Agreement
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