- Contracted to get the organisation ISO 13485 certified
- Customer communication section 7.2.3 - How have other companies handled this section
- Exception to 6.4 a) thru d) - Excluded from the Scope of my Quality System
- Minimum Quality records required by ISO 13485
- Document Pagination - Is FDA strict about Document Pagination?
- Evaluating competence on training for new ISO 13485 standard for employees
- MDD and LVD compliant - Device that passed the safety tests of 601-1 and 335-1
- Religious head coverings (e.g., yarmulke) and Cleanrooms
- Definition needed in ISO13485 - 7.5.1.1 b) - Reference Measurement Procedures
- Syria regulations - Registration and sale of medical devices to Syria
- Effective Control of Processes - ISO 13485 Clause 4.2.1 (d)
- Planning of Product Realization - Risk Management - ISO 13485 Clause 7.1
- Initial sample approval guidelines - PPAP, FAIR, etc. for medical devices
- ISO 13485:2003 Quality Policy Controlled with a Revision date and number?
- GMP, FDA and ISO13485 Differences
- MDD Requirement - SOP for on how to translate from one language to another
- Explain the process validation procedure in the manufacture of IVD products
- ISO 13485 Clause 6.3 - System to determine and provide infrastructure
- How is risk management handled in a software-based product
- Request for ASQ Biomedical Division Members input on Global Harmonization Task Force
- Contract manufacturer seeking help understanding ISO 13485 Validation requirements
- Custom impressions for hearing aides - What types of quality control processes?
- MD's and non-MD's Technical Docs
- Process Interaction Chart example as required by ISO 13485 2003
- FDA Quality Plan - What kind of quality plan is required for FDA QSR?
- CE requirements for invitro diagnostic device which has an electronic reader
- Auditor stating we have to be audited to 13485:2003 before we are audited
- Additional Regulatory Requirements for Medical Device
- Are C of C's from Suppliers Required? Medical Class I and II devices
- Registered to ISO 13485 and Outsourcing some manufacturing to an ISO 9001 company
- Medical device sterilization - Anyone know any service vendors in mainland China
- Questions for a software vendor, Statistical process control software
- ISO 13485 obsolete products - Obsoleting a medical device product
- Setting up a Quality system - No medical device experience - Where to start
- Concurrent Manufacturing and ISO 13485 Implementation
- Why ISO 13485 not ISO 9001 for medical devices?
- ISO 13485 Manual and Procedures, needed
- Need for special Labeling - Prototype which can not be operated
- New standard 'impact assessment' - Essential Requirement/Principles Checklists
- Harmonised Standard and Essential Requirements
- Keeping prototype devices - Is there a regulatory or compendial requirement?
- Sample Sizes for Process Validation - Medical device manufacturer
- Does the MDD obligate the “legal manufacturer” to disclose the manufacturing location
- ISO 10005 Guidelines for Quality Plans - Do we need an SOP?
- Process correlation matrix - Just how far "into the weeds" do I go?
- MDD inclusion in Quality Policy - MDD Annex 5, 3.2 was referenced
- Medical Devices FDA 510k third part review? Class II Medical Device
- Medical Products - Cleanroom Requirements - Plastics injection molding - ISO 13485
- Contract Manufacturer Registering with the FDA - Medical devices - 21 CFR 807.20
- MDD Audit Plan that covers ISO 13485 sections and the MDD sections
- Top level CAPA (Corrective and Preventive Action) procedure
- Reaudits (CFR820.22 Quality audit)
- Risk Management Plan for a Class III Medical Device (Bone Void Filler)
- Biocompatibility - USP Class VI vs. ISO 10933
- How to define Product Lifetime - IVD instruments (no reagents) - ISO13485
- The nonconforming product definition applies for the purchased products?
- ISO13485:2003 vs. the Japanese PAL Ordinance No. 169 - Seeking Gap Analysis
- Document that specifies PQ and sample size
- Is there any mention of technical and geographic scope in 13485?
- Customer Corrective Action - Only one part and a cheap one at that
- Approved Supplier List vs. Auctions - One-Time Equipment Buys
- Procedure Approval - SOPs signed by the President and Regulatory Affairs
- Does anyone know where to buy an instant read dosimeter?
- Gamma Sterilization Validation Documents - 13485:2003 section 7.5.1.2.1
- TX Department of State Health Services audits for the FDA related to medical devices
- Which devices are required to meet USP Class 6 or other biocompatibility requirements
- Directive 93/42/EEC Classification crtieria - Definition - Surgically invasive device
- How to verify the SAL (sterilie acceptable level) is 10-6 for ETO Sterilization
- Biocompatibiltiy testing of materials (ISO 10993-1) vs. Testing of final product?
- Process Validation from an FDA standpoint - The GHTF document
- CE technical file - Buying Surgical Mask from China
- FDA approval? Contact lenses which are classed as medical devices
- Is Smoking Cessation Device a Medical Device?
- Line Clearance - What is the ISO 13485 / regulatory guidance?
- Moving to a new facility - Class I and II medical devices - Words to the Wise?
- When is a system not a single device? Does anybody know of a guidance document?
- Clean room requirements for sterile wound dressings
- FDA Compliance Manual, Inspection of Medical Device Manufacturers, Available
- Returning used medical devices to the manufacturer for complaint investigation
- Decontamination of Customer Returned Product - Seeking sample procedure
- Applicable standards EC type examination - Sterile plastic nebulizers
- Molding Validation procedure - New medical component
- QSR (Quality System Regulation) Overview Training powerpoint .ppt presentation
- EtO vs. Gamma Sterilization - Stainless Steel and Titanium Orthopaedic Implants
- I need help regarding product responsibility in relationship to FDA
- List of mandatory or required procedures for 21 CFR Part 820
- Sterilisation Validation - VDmax for e-beam
- Risk Analysis on Medical Device Instructions for Use?
- Reusing similar device's risk analysis
- Anyone with experience in open-source firmware in medical devices
- Labeling Responsibility - Manufacturer vs. Repacker? Proper Component Use
- Medical vs. Non Medical - Differences in Quality Systems
- FDA CFR 21 / 11 - Keep the records we scan in using Adobe?
- The number of ISO13485 posts in the Elsmar Cove forums
- Are there any New Regulations for Medical Devices?
- Sample Retention - Quantity, Retention Period, Storage
- Label Translation SOP - MDD or ISO 13485 requirements?
- Cosmetics (otc) with Drugs - Expiration dates and three years stability / shelf life
- Mold Material Standard - Material for making molds supporting medical devices
- How about the classification under 93/42/EEC? Sterile oxygen mask
- Device History Records (DHR) Component Traceability / Serial Number Requirements
- Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
- ISO 9001 Quality Policy Manual vs. ISO 13485 Quality Policy Manual
- Specific records to be retained for Class II devices per 820.184 DHR
- Business Continuity for IVD manufacturers - Our most severe risk is fire
- List of Harmonized Standards for the MDD, IVD and IMDD - June 2006
- Standards that exist regarding Sterilization of Polypropylene?
- ISO 13485 Process Model Diagram - Does anyone have one?
- IVD Directive - Review and Update Essential Requirements Documentation
- DMR Index - Can someone share their Device Master Record Index structure or format?
- Bone Cement and Contrast Medium for X-Ray Purpose - A Combined Product?
- Which Subcontractors or Facilities need to be listed on a Quality System Certificate?
- Regulatory Requirements for North America regarding ISO 13485:2003
- Regulatory Requirements for ISO 13485 - Which country to decide?
- Quality System Manual - We have a section of our QSM entitled Servicing
- ISO13485 Sterilisation Validation, Risk Management, Post Market Surveillance
- MDD Approval Route by Change of Manufacturer
- Added Value Benefits for a Warehousing Company to be ISO13485 Registered
- Assessment of Technical Information of Annex II Medical Devices
- Drinks on the shop Floor? Stainless Steel Medical Devices
- Quality Plan for Contract Manufacturer - Medical Devices
- Dress Code in ISO Class 8 - Plastic Parts for Medical Devices
- Advisory Notices - What is the Requirement in ISO 13485
- Status ID - Mark Each Unit Individually? Clause 7.5.3.3 and and GMP section 820.86
- ISO 13488 to ISO 13485 - ISO 13488 Certification Status Question
- Identification & Traceability - ISO13485:2003 - Clause 7.5.3.2 - Distributors
- Auditor Access to Records - How far an Auditor can Probe
- cGMP calendar and ISO 13485 - Does ISO 13485 QMS require a cGMP calendar?
- Clinical Audits to ISO 14155 - Performing audits of clinical affairs groups
- Disaster Recovery Plan - I cannot find references to same in ISO 13485
- Is FDA Approval Too Expensive? The Cost of Doing Business in the Medical Industry
- Defining Complaints - Product malfunctions or failures
- Audit questions and plan for ongoing audits of ISO13485:2003
- Need Information - FDA Silver or Gray Sheets - August or September '06
- Identifying Raw Material Part Numbers - Product Identification and Traceability
- MDR Canada vs. MDR USA
- Computer software validation system in medical device industry
- Combinational Device - Fluorescence Dye - Fluorescence Intraoperative Procedure
- Cost of ISO 13485 Certification high compared to ISO 9001, TS 16949 and ISO 14001
- Medical Devices QC Testing Procedure - Flexible Medical Solution Bags
- Advice on "Country of Origin" regulation with regard to medical devices
- Do we need to Validate Outsouced Processes? ISO13485
- Does a Radiotherapy device need a clinical trial for getting registered in China?
- Quality Policy: ISO 13485 vs. ISO 9001 (or AS9100 or..)
- Mold Receipt Process - Medical Devices
- Is a written procedure required for handling significant change?
- Canadian Licensing to sell Class I and Class II Devices in Canada
- Advisory Notices - Who is responsible for dealing with Advisory Notices?
- Risk Analysis for a Subcontractor
- Air changes calculator which calculates total number of air changes in Cleanroom
- Booklet on Medical Devices for the benefit of all our employees
- Medical Device 510k Requirements - Plan to expand the manufacturing site in Malaysia
- Endotoxin testing - Raw materials and components of a Class III medical device
- Specifications or guideline for topical patch medical device
- Do we have too many operational procedures and are they too long?
- CE Marking using the ISO13485 Registration Process
- Differences between Sample Sixes for Design Verification vs. Process Validation
- Dual cert (9001 & 13485) - How to audit the 1 medical device we manufacture?
- Any adhesive needed for PVC and PC natural bond?
- CAD files in a submission to FDA
- Submit a 510(k) to an existing device vs. Just Documenting a Change
- Supplier audit - Are they asking for too much documentation?
- First ISO13485 accreditation audit: What are things that can go wrong?
- Form to send to a supplier of QC services for their evaluation needed
- 510(k) Screening Checklist that the RA has filled out - Is that sheet for FDA use?
- Presentation on Quality Systems - URGENT
- Frustration - New to the Medical Device field, I come from generic pharmaceuticals
- TUV NCR No: 1 - Autoclaving: The process validation does not comply
- TUV NCR No: 2 - Aseptic processing validation has not been performed
- Records Requirements - Question about Clause 8.4 Analysis of Data
- Mutual Recognition Agreement (EU and Australia) - Medical devices
- Blocking a Mold Cavity - 16 cavity mold which has been validated for a part
- Monitoring and measurement - 7.6 of ISO 13485 - Documented procedure required?
- Ownership of 510(k) to transfer or submit new one - Class 1 medical device
- I need the ISO 13485 Standard manual. Where can I buy it?
- CE Classification of Phacoemulsification device
- Documentation required for launch of a non-sterile exempt class 1 medical device
- FDA site database search - Where to find listing for PMA and 510(k)
- Validating Custom adaptations of Medical Devices
- ISO 13485:2003 documentation vs. ISO 9001:2000 documentation - Differences
- Introducing a risk/impact assessment to nonconformity procedure
- Organizational Chart - Manufacturing Manager report to Director of Quality
- Japan Classification of Phacoemulsification Device
- ISO 13485 sample document or template - Class II medical device
- In-process check frequency - Class I devices on the filling and labeling lines
- Where can I find a standard or tests for drug reservoir material testing?
- Help on NDCs and Cosmetics that contain a "Drug Product Active Ingredient"
- What is required to export Class I (non exempt) 510(k) approved product to Mexico
- FDA Part 820 Quality System Regulation - 820.198 Complaint files
- 'Retained Quality Samples' from each manufacturing batch - Thoughts on this please
- Regulatory requirements for export of Medical Devices to Thailand, Australia and US
- DHF on new medical device product
- Complying ISO 13485 - Require other documentation specified by regional regulations?
- Who is in charge of Vigilance reporting in your company?
- Certified IT components in Medical devices, class IIa (EU)
- Company purchased by holding company - What quality changes are needed?
- Calibration vendors considered Critical?
- Limited Calibration requirements in ISO 13485 - Temperature controller
- Pad Printing Ink Requirements for pad printed medical device
- PVC Tubing Extrusion - Class I medical device
- Validation Requirements: ISO 9001 vs. ISO 13485?
- Removing the liner from disposable nicotine patch without using hand
- Procedure for Handling Medical Customer Visits - Please review
- How to accomplish ISO 13485 Clause 8.2.3 Monitoring and Measuring?
- Medical Device Classification question - Inventory Control devices and software
- Selecting a predicate device for FDA 510(k) approval
- Medical Device Reimbursement - Europe
- Does 21CFR11 only apply to records that are completed electronically?
- Update to ISO13485 / 14969 - Request for assistance from ISO/TC210 Working Group
- Medical Device Kit requirements
- We completed our first annual ISO 13485 Continuing Assessment Audit
- Labeling Requirements for a Class 1 Exempt Medical Device
- Exempt from FDA Registration or not? Company that makes parts for medical devices
- Differences between ISO 13485 and ISO 13488
- Maintenance of Class 9/8 clean room in a medical devices factory
- ETO Sterilization of Urological Catheter
- Regulatory requirements for Medical Device Manufacture in India
- FDA Site generic Supplier Related forms help needed
- Chlorine dioxide for medical use - Alternative for the disinfectants?
- Number of copies for an FDA additional information request?
- Tracking new or revised regulatory requirements
- Quick Overview of the Standards for Medical Devices - ISO 13485:2003 and ISO 14696?
- 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"?
- 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
- Advice or accepted standard for lot numbering - ISO 13485
- 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
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