- Design Control - A Simple Sample APQP Matrix - 21 CFR 820.30(b)
- The Don Winton Memorial FDA Stuff Archive
- ISO 13485 ISO 13488 vs. EN 4600 EN 4601 Series
- FDA has auditing guidelines posted on it's web pages for QSR
- Design Input - 820.30(c) - Addressing incomplete, ambiguous... requirements
- What MUST be signed and dated? FDA QSR requires signatures for specific sections
- Design Validation According to § 820.30 g
- Classification rules for Canada - Electrosurgical and Cryosurgical Equipment
- Medical Device Industry Links
- Technical Reports - Class 2 medical device design and manufacturing
- Design History File - Medical Device Quality Systems Manual Section 3, Design Control
- Graphical Symbols - EN 980 - Labeling of medical devices and EN 60601-1 symbols
- Systems Requirements Mandated by EN46001 and EN46002
- Purchasing Procedure - QSR §820.50 and ISO 9001:1994 Clause 4.6
- Design Control Necessary - Specification development company
- Process monitoring - Stationary and portable oxygen units
- Verification Activities - Clinical Medical device manufacturer
- Continuous Certification - ISO 9001 Certified EN4600 - Why the 3 year recert audit?
- ISO 13485:1996 - EN 46001 - Medical devices - Particular requirements - ISO 9001
- Where can I buy EN46000?
- Passivation Validation - Is passivation is considered a "special" process by the FDA?
- FDA QSRs and ISO 9001:2000 - CFR 21 Part 820 and CFR 21 Part 58
- QSR Purchasing Controls governing evaluation and use of consultants
- History and Current Status of ISO 13485?
- Particulate On Final Implantable Devices
- I would like to know the requirements for USFDA approval
- Looking at 21 CFR 820.20 which calls out in section (d) for Quality Planning
- En 550/554 - The European Commission Standards Harmonization
- Software Validation - CAD-type program that will produce Engineering drawings
- 21CFR820 vs. ISO 9000:2000 - Cross Reference Matrix Attached
- Food and Drink in Production Areas - Manufacturer of FDA analytical and diagnostic
- What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820?
- cGMPs, Quality Requlations for Drug Manufacturer's & Their Suppliers
- Quality Regulations for Drug Manufacturers & Their Suppliers
- Clinical Trials in Europe - What is the "competent authority" in Italy?
- Notified Bodies - Notifying Customers when Changing Registrars?
- Pursuing certification to ISO 13485 (actually 13488)
- Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000
- Micro Contamination - Emoderivates (producing albumin, etc from human plasma)
- Where can I buy ISO 13485?
- ISO 13485 and ISO 17025 Interface - Laboratory vs. Parent Company
- Anyone know Coca Cola's (Coke) QA system?
- Finished product visual status - Each box must have a QC status identifier?
- EN46002 vs. ISO 13485 - Transition Route
- Building a new cleanroom - ISO 14644-3 or ISO 14644-4
- Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
- ISO 13485:2003 Status: Published
- Identification and Traceability in Medical Device Tracking - FDA Requirements
- Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003
- Looking for Registrar to audit using ISO 13485:2003
- ISO 13485:2003 Compliance Audit Checklist - Example Attached
- FDA Quality Audits 21cfr820.22 - Audits by the head of the company not allowed
- New Clause Structure of ISO 13485:2003
- ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist
- To IDE or not to? FDA/CDRH website/guidance documents too hard to understand
- Accelerated Stability Studies - In vitro Diagnostic Devices
- Safety Lancets Manufacturer - What is the testing standard used for lancets?
- Integrating ISO 13485:1996 with ISO 9001:1994
- CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audits?
- Iso 11135:1994 - Validation and Control of Ethylene Oxide Sterilization
- Whats the difference, ISO vs EN ISO Std's
- Applicability of Risk Management for Medical Devices - ISO 14971:2000
- ISO 13485 Certification - Class II product - Fluoride-free toothpaste - Records
- ISO 9001 / ISO 13485 - What is considered a 'documented' procedure?
- ISO/CD 14969 - Draft of the Guidelines to Implement ISO 14385:2003
- Where to Document Exclusions per ISO 13485 and ISO 9001
- Where can I buy ISO 13485?
- 13485 Calibration Requirements - Requiring a Documented Procedure for control?
- FMEA vs. Risk Analysis - What are the differences - Medical Devices
- Microbiological Testing - Bioburden and Identification of Micro-Organisms
- Conversion from ISO 9001:1994 to ISO 13485:2003
- Medical Device Component Suppliers - Require ISO 13485 system?
- ISO13485:2003 - Certification Bodies are accredited by UKAS
- OTC S/W in Medical Devices (managing obsolescence)
- ISO 11137:1995 Sterilisation of healthcare products - Amd1:2001
- Servicing of Wheelchairs (wheel chairs)
- Cleaning of Miscellaneous Items - Equipment and materials that are reused / recycled
- Device Labeling Standards: Is ISO 15223:2000 Replacing EN980?
- FDA Question: Contents of an FDA 510(k) Submission
- Verification & Validation (V&V) Traceability - What are the benefits and limitations?
- How many CBs have been accredited to perform ISO 13485:2003?
- Medical Industry - Nominal Quality Requirements
- Get your free ($6.95 Value) GMP Pocket Reference
- Medical Electrical Equipment & UL Approval - Interpreting the Life-Cycle Diagram
- Transition training for 13485:2003 - Seeking Recommendations and Comments
- ISO 13485 Procedures - Seeking Examples - Small Manufacturing Company
- Ratio of Quality vs. Manufacturing Staff in Medical Device Industry
- Document Issue & Control in ISO9000-3 - Medical software
- Contract Manufacturing Pre-Qualification? How much 'due diligence' to satisfy the FDA
- FDA Establishment Registration - Does registration require compliance to the QSR?
- NCR under MDD - No documented procedure for class I device registration mechanism
- EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD
- Life Cycle Approach to Setting Specifications for Biotechnology-Derived Products
- EU rainbow trout feed regulations
- Rework Requirements - ISO13485 Part 8.3 vs. FDA QSR
- ISO 14971 replaces EN 1441 - Risk Analysis and Technical Files/Device Master Files
- Clean Rooms Training - Particle release (personel), Sedmentation velocity of particle
- Document Change Order - DCO templete which complies with FDA QSR requirements?
- Planned vs. Unplanned Deviation & Nonconformance
- Medical Device Directive 92/42 EEC - Clinical Trials - Because the auditor says so?
- Seeking: Source for IOS International Symbology for OTC products
- Software Development Plan - Startup Software Development Company - 13485:2003
- Getting Started - ISO13485:2003 and MDD (Medical Device Directive)
- Device Defect Training? - Personnel shall be made aware of device defects
- Risk Management ISO 14971 - Samples and How to Go about it
- When does an engineering change become a design change?
- 13485:2003 7.5.3 and 8.4 - Seeking examples of procedures needed for these clauses
- 7.4 Purchasing - Query on Indirect Material Qualification
- Non-sterile - Does anyone know of a universal symbol?
- Starting ISO 13485:2003 Registration - Introduce Myself
- Guidance for Understanding ISO 13485
- ISO 13485 (EN 46000) or ISO 9001 - Which Standard? Sterilization within a Hospital
- Looking for UK DH Document TRS 89 - Diagnostic Imaging and Radiotherapy
- Management Representative - Is there a requirement for a substitute management rep?
- ISO 9000:2000 and ISO 13485:2003 impact on the MDD 93/42/EEC
- ISO 13485:2003 6.4 vs 7.5.1.2.1 - For me these paragraphs are very close
- Sensitivity vs. Specificity - FDA won't even allow those words
- Customer notification of processing changes - Class I medical devices
- Legislation for Safety Devices - Needlestick Safety and Prevention Act (HR 5178)
- ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix
- New to ISO13485 and FDA requirements - How and Where do I start?
- And now, let's add software development - Medical Devices - Applying ISO9001:2000
- Steam sterilization standards - Temperatures, pressures, and time numbers
- Changing a UK Notified Body - Anyone with any experience?
- Rate your FDA Audit Experience
- What to do once an FDA Inspection is over - Seeking FDA site Link
- How do I ensure QSR compliance in an FDA company within 12 months
- When no training is required, How do I document that no training is required?
- Regulatory requirements to sell and market medical devices in Australia?
- Line clearance - Routine components in the prep room for universal use
- 510(k) Document Creation - What are the Rules?
- All software need validation? Softcopy Specifications copied to CD
- FDA seeks injunction against a Utah medical device manufacturer
- ISO14971:2001 - Risk Management for Medical Devices - Help need copy
- ISO 13485 vs. Japan's Pharmacutical Affairs Law
- Purchasing process needs for R&D department - IVD Medical Devices
- Chinese Standards - Specific deviations in adoption of various IEC standards
- Discontinuing A Medical Device - Support requirements - Class 2 Medical Device
- Using Rational Unified Process for Medical Device Software
- ISO 13485 - why keep 9001 registration
- ISO 13485 : 2003 - When must the transition be completed in Japan?
- Risk assessment & Product development - All products - Medical device or not?
- Raw Materials verification - Melt Flow Test - Resins: Customer not Satisfied
- Implant Contamination - 17-4 SS Devices - Machine Shop
- What is the transition deadline for ISO 13485:2003?
- ISO 13485 - 8.2.1, 8.4, 8.5, and 8.5.2/3 - Specific Procedures Needed?
- Marketing Requirements vs Product Specifications
- Medical Device: QSR and Clinical Trials and Design Controls
- Document control - ISO 13485:2003 - Obsolete controlled documents shall be retained?
- 21 CFR 820 QSR 820.25 Statistical Techniques Procedures Requirements
- ISO 13485 - List of required / needed procedures and records attached
- What is the most effective way to integrate CAMDCAS requirements into Quality Manual?
- How to verify SOP training effectivness - Section 6.2.2 in ISO 13485
- ISO 13485:2003 QMS Flow - I have just put together my first draft
- How do you control your clinical documents, like surveys, consents, authorizations?
- Japanese Market - Any special requirements (regulatory or quality)?
- Audit of medical device company with prototype of product
- Device Serialization - Generating a unique identifying serial number
- Technical & Risk Management File - Subcontract manufacturer
- Draft Revision of EU Medical Devices Directive 93/42/EEC
- FDA won't take any action as long as you can show effort
- FDA will not make a company comply with a regulation if it causes undue hardship
- How do I meet the Medical Devices Risk Assessment requirement?
- Certifying a PDA as a medical device - (FDA/CE) - For use in the operating room
- Implementing ISO 13485:2003 - 8.5.1 - Advisory Notices - Recall Procedure
- Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC)
- Job shop seeking QMS intends to manufacture devices, is ISO-13485 appropriate?
- System Requirement - FDA - Software Validation on various OSs
- Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1)
- CE Language Requirements on labeling (both device and packaging)
- MDD class IIa Annex V or VI: specific doubts when implented
- FDA ASTMF1100 replacement? We want to market an emergency care ventilator
- Is a component of a pedical screw system considered a finished medical device?
- IS0 13485:2003, Validation of the application of computer software
- Class 2b USB enabled diagnostic devices...Clinical trials
- Redesign of a product prototype - CAPA or not? Medical Device
- ISO 13485 Gap Analysis Checklist - Updating ISO 13485 from the 1996 standard to 2003
- Environmental Control Standards - Sterile medical device manufacturing environment
- ISO 13485 & ISO 14971 - Requirements for risk management
- DMR - Device Master Records - What is the best way to structure the DMR
- Use of CD roms in labeling of Medical Devices
- Preparing for initial FDA inspection - What must I do?
- FDA standard approval list - ANSI/AAMI SP10 - 1992 revision approval
- Medical Device Directive manufacturer - Wanting to outsource some proceses
- Disposal requirements - Contamination from waste products and medical device disposal
- ISO 13485 - Risk Assessment for medical device job shop
- I've inherited a mess - New to the Regulatory/Quality area - ISO 13485
- Feedback System (8.2.1) - Requirements for "..establishing a documented procedure..."
- New Quality Policy - Feedback Wanted
- Environmental Monitoring - Microbial Identification - Small medical device company
- Looking for a table that quantifies Likelihood/Probability of occurrence of a hazard
- ISO 13485: 2003 - Clause 8.4 Analysis of Data - Seeking an example procedure
- ISO 13485 - Cleanroom Operator Training Requirements
- Design help needed - Isoflurane compatibility with polymers - Anesthesia gas
- Global Medical Device Nomenclature (GMDN) Code
- Ansi/aami/iso13485:2003 + Iso14971:2000 + Iec60601-1-4:2000 + Mdd93/42/eec
- ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit
- Bar coding - Medical device labelling - New Japan requirements
- Looking for a sample MDR and complaints procedure - Medical Devices
- Revision of MDD, 93/42/EEC - Has the final revision been published?
- Design Input and Output Documents - Seeking specific examples - Medical Devices
- Internal Audit of China factory of Medical devices - need guidance
- How to Produce a Technical Fle - EC Marking Guidance Needed - MDD 93/42/EEC directive
- List of Countries Using ISO standards (medical devices in particular)
- 13488:1996 vs. 13485:2003 Gap Analysis Matrix Spreadsheet
- ISO 13485, cGMP and ISO 9001 Gap Analysis
- Virtual Manufacturing and ISO 13485 - Cardiovascular products
- Export Of Approved Canadian Medical Devices - What export certs are needed
- ISO 13485 Exclusions - Production-related requirements - Section 7.5
- Seeking Quality System Input/Output Matrix
- Documented Procedures for the Issue of Advisory Notices and the FDA (Medical Devices)
- Tissues of Animal Origins
- Do Quality System Documents have to be in English (for USFDA onsite inspection)
- Alcohol Free vs. Alcohol Based Sanitisers - Your Opinions or Experience?
- Is 13485 applicable to distributors of medical devices?
- Software validation question - Contract Manufacturer - ISO 13485 implementation
- Guidance required in relation to refurbishment / remanufacturing of a Medical Device
- MDR fixes - Resolutions to MDR's for out-of-contract customers
- Medical Device Release Form
- Who is the customer for our certified area?
- ISO 13485:2003 Documentation Requirements for Outsouced Processes and Services
- Asked to introduce a Blades (Knives) policy into the company
- Risk Analysis Question - Estimating the likelihood of a hazard occuring
- Medical Device EMC requirements - Canada - Testing to FCC part 18, EN 55011, EN 60601
- What types of Quantitative Results are required in 510(k)
- Requirement to be registered to ISO 13485 by the end of 2006?
- Proposed Revision to the Medical Device Directive
- Qualified Registration Bodies (CMDCAS) one has been suspended
- A Question of Sorts - Why register to both ISO 13485:2003 and ISO 9001
- 13485 6.2.2 c) "evaluate the effectiveness of the actions taken" (training)
- Foley Catheter Color Size Chart
- Is a Contract Review Procedure necessary to comply with ISO 13485:2003?
- Looking for help re: EN980 manufacturing symbol
- Classification of medical devices in Canada
- Sterilization Validation ISO 14937 - Sterilizer that uses EO gas diffusion
- Nuclear Medicine Dose Calibrator Classification (MDD)
- Do we require compliance to ISO 14971 (Risk Management)?
- Medical Device Class I and Class IIa Differences? Inhalator
- What are the standards needed for an electro-acupuncture device?
- Specialised Medical device, Pharma & electrical AHESIVES, COATINGS - Seeking Info
- QSR vs. ISO13485:2003 - Seeking a a comparison list of differences
- Fast ISO13485:2003 Implementation - What would you do first?
- Seeking a Comparison Guide - ISO9001 vs. ISO13485
- MD Directive vs EMC Directive - Totally excluded (for both emissions and immunity)?
- Canadian Certification Required for a USA-Based Class I Medical Device?
- JGMP and ISO 13485:2003 - The Japan GMP related to medical device
- ISO 14971 and 13485 - Is ISO14971 just a supplement to ISO13485?
- Software Standards for medical devices
- Classification as medical device or non-medical device?
- Are you operating a class 9 cleanroom? Share cleanroom monitoring results?
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