ISO 13485 FDA 21 CFR 820 QSR Medical Quality System
Customized Turnkey 21 CFR 820/ISO-13485 Quality System
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Thursday, September 25, 2008 |
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Saturday, October 25, 2008 |
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Germantown, MD |
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Description
If you are a Class I or II Medical Device Developer or Manufacturer, you are required by law to be compliant with the FDA Quality System Regulation (21 CFR 820). We can custom-tailor a complete 21 CFR 820/ISO-13485 compliant Quality Management System (QMS) for your company in just 10 days for only $7,490 (includes all consulting and service fees). Our comprehensive QMS is fully compliant with the following regulations: 21 CFR 820* ISO-13485:2003 ISO-14971:2000 MDD 93/42/EEC (European Medical Device Directive) CMDR SOR/98-282 (Health Canada) Numerous companies who have implemented our Turnkey QMS have successfully achieved ISO-13485 Certification and passed FDA Level II Quality System Inspection Technique (QSIT) audits. We are supremely confident in the effectiveness of our QMS! This is not a one-size-fits-all DIY software product. This is not a CD full of Procedures and Forms that you have to develop into a working Quality System. This product is a completely implementable ready-to-sign QMS consisting of 31 document binders (and an electronic copy in MS Word) developed by us specifically for your company. In addition to the Quality Manual, the following Standard Operating Procedures (SOPs), Quality Processes (QPs) and ready-to-use Forms are provided: Standard Operating Procedures SOP-01, “Management Responsibility” SOP-02, “Quality System” SOP-03, “Contract Review” SOP-04, “Design Controls” SOP-05, “Document and Data Control” SOP-06, “Purchasing”” SOP-07, “Customer Supplied Product” SOP-08, “Product Identification & Traceability” SOP-09, “In-Process Control” SOP-10, “Inspection and Testing” SOP-11, “Control of Inspection, Measuring and Test Equipment” SOP-12, “Inspection and Test Status” SOP-13, “Control of Nonconforming Product” SOP-14, “Corrective and Preventive Action” SOP-15, “Device Packaging, Handling, Storage, Distribution and Installation” SOP-16, “Control of Quality Records” SOP-17, “Internal / External Audits” SOP-18, “Qualification, Certification and Training Process” SOP-19, “Servicing” SOP-20, “Statistical Techniques” SOP-21, “Complaint Handling System” SOP-22, “Vigilance System” Quality Processes QP-01-01, “Medical Device/Establishment License” QP-01-02, “Obligation to Inform” QP-03-01, “Order Processing” QP-04-01, “Design and Development Planning” QP-04-02, “Design Reviews” QP-04-03, “Design Input” QP-04-04, “Device Classification for MDD” QP-04-05, “Device Classification for Health Canada” QP-04-06, “Device Classification for FDA” QP-04-07, “Risk Analysis Planning” QP-04-08, “Design Output and Verification” QP-04-09, “Design Validation and Design Transfer” QP-04-10, “Software and Electronics” QP-04-11, “Design History File” QP-06-01, ”Purchasing Process” QP-06-02, ”Verification of Purchased Product” QP-14-01,” Improvement” QP-19-01, “Decontamination Procedures” QP-22-01, “Incident Report Process for MDD” QP-22-02, “Incident Report Process for Health Canada” QP-22-03, “Recalls for MDD” QP-22-04, “Recalls for Health Canada” Forms F-01-01, ”Management Review Report” F-01-02, ”Organizational Chart” F-04-01, “Project Initiation Document” F-04-02, “Product Description” F-04-03, “Master Project Plan” F-04-04, “Design Review Report” F-04-05, “Feasibility Report” F-04-06, “Design Input Document” F-04-07, “Risk Analysis Plan” F-04-08, “Verification Plan” F-04-09, “Manufacturing and Quality Plan” F-04-10, “Regulatory Submittal for FDA” F-04-11, “Essential Requirements Checklist for MDD” F-04-12, “Declaration of Conformity for CE” F-04-13, “Declaration of Conformity for Canada” F-04-14, “Process Validation Report” F-04-15, “Validation Plan” F-04-16, “Design Transfer Plan” F-04-17, “Software Requirements Specification” F-04-18, “Software Design Specification” F-04-19, “Traceability Analysis” F-05-01, “ERO/ECN” F-05-02, “Deviation Request” F-05-03, “Quality Agreement” F-08-01, “Label Review” F-06-01, “New Supplier Approval Evaluation” F-06-02, ”Quality System Audit” F-09-01, “Preventive Maintenance Schedule” F-09-02, “Master Validation Plan and Protocol” F-10-01, “Receiving Inspection Log” F-11-01, “Inspection, Measuring, and Test Equipment Documentation” F-13-01, “Nonconforming Materials Report” F-14-01, “Corrective Action Request” F-14-02, ”Preventive Action Request” F-16-01, “Device History Record” F-16-02, “Department Quality Records” F-16-03, “Software Revision Level History” F-17-01, “Internal Quality Audit Schedule” F-17-02, “Internal Audit Report” F-17-03, ”External Audit Report” F-18-01, “New Employee Training Checklist” F-18-02, “Employee Training Record” F-18-03, “Training Evaluation” F-19-01, “Service Report” F-21-01, “Complaint Report” F-22-01, “Competent Authority Listing” F-22-02, “Minister of Health Address – Health Canada” F-22-03, “Initial Incident Report for MDD” F-22-04, “Initial Incident Report for Health Canada” F-22-05, “Final Incident Report for MDD” F-22-06, “Final Incident Report for Health Canada” Our product includes everything your company requires to be compliant with the FDA QSR, ISO-13485, the MDD and CMDR. Terms: 20% due at start of project, balance due upon completion. Company check or PayPal accepted. Binders will ship via UPS ground & electronic copy via email. We can also assist your company in the implementation of your ISO-13485 QMS and provide additional services including 510(k) (Class I & II) preparation & submission. We have a certified Regulatory Affairs consultant available to assist you with any regulatory matters. * Code of Federal Regulations, Title 21 (21 CFR) Part 820 Quality System Regulation; Part 803 Medical Device Reporting; Part 806 Medical Device Corrections and Removals; Part 821 Medical Device Tracking.
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