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OverviewOrganisation ChartStaffRolesProjectsSOPsTemplates
Templates
510k FileCEF - Clinical Evaluation FileCSF - Clinical Study FileCustomer fileDHF - Design History FileDHF - Design History File - SWDHF - Design History File - SystemDHR - Device History RecordDMR - Device Master RecordETF - European Technical FileLabelsMHR - Module History RecordMMR - Module Master RecordPHR - Process History RecordPMR - Process Maser RecordPersonal fileStampsSupplier file
«document» AE surveillance report«document» Applicable standards«document» Application form QM certification«document» Application form product examination«document» Application idea«document» Application manual«document» Application training manual«document» Authority to sign«document» Briefing checklist for new staff«document» Business contract«document» CE medical device classification«document» CI and CD guideline«document» CIP (Clinical investigation plan)«document» CM tools and equipment list«document» CRF - Case Report Form«document» CS clinical training raw material«document» CS trainer training material«document» CS trainer training report«document» Calibration certificate«document» Calibration report«document» Certificate of successful clinical surgeon training«document» Checklist release of trade products«document» Cleaning process instructions«document» Clinical evaluation plan«document» Clinical evaluation report«document» Clinical evaluation search terms«document» Clinical investigator brochure«document» Clinical literature search report«document» Clinical publication«document» Clinical study design«document» Clinical study forecast«document» Clinical training forecast and plan«document» Clinical validation application«document» Company floor plan«document» Company inventory list«document» Company mission«document» Compatibility to other medical devices«document» Competency rules«document» Competitor IP description«document» Component specification«document» Contract sponsor - monitor«document» Contract sponsor - principal investigator«document» Control of documents and records«document» Copy of inventor's workbook«document» Creditor invoice«document» Creditor invoice (Hardcopy)«document» Customer basic training certificate«document» Customer feedback«document» Customer focus«document» Customs declaration«document» DATEV Personalfragebogen«document» Debitor invoice«document» Declaration of conformity for CE«document» Declaration of unlimited use«document» Decommissioning report«document» Deed of assignment«document» Delivery note«document» Delivery note«document» Design Specifications (DS)«document» Design concept«document» Design qualification (DQ) instructions«document» Design qualification (DQ) report«document» Design verification plan«document» Design verification report«document» Design-FMEA (DFMEA)«document» Device BOM«document» Device Hazard Analysis (DHA)«document» Device acceptance test instructions«document» Device acceptance test report«document» Device classifications«document» Device decontamination report«document» Device field acceptance test instructions«document» Device field acceptance test report«document» Device history«document» Device incoming inspection instructions«document» Device incoming inspection report«document» Device installation instructions«document» Device installation report«document» Device inventory«document» Device manufacturing report«document» Distributor agreement«document» Document list«document» Drawings with check dimension«document» EC design-examination certificate«document» ECN-Engineering Change Notice«document» ECO-Engineering Change Order«document» ECR-Engineering Change Request«document» Employee objectives«document» Equipment maintenance plan«document» Equipment maintenance report«document» Essential requirements machine directive 98/37/EEC«document» Essential requirements medical devices 93/42/EEC«document» Ethic commission votum for clinical study«document» Ethic commission votum for clinical validation«document» External audit plan«document» External audit report«document» FDA medical device classification«document» FSCA customer feedback«document» FSCA customer notice«document» Facility cleaning plan«document» Facility cleaning report«document» Facility maintenance plan«document» Facility maintenance report«document» Facility pest control plan«document» Facility pest control report«document» Final report clinical study design«document» General company calendar«document» General marketing strategy plan«document» Glossary«document» Hand over protocol«document» House of Quality«document» ISO 13485 Certificate«document» IT maintenance plan«document» IT maintenance report«document» Installation protocol client«document» Installation qualification (IQ) instructions«document» Installation qualification (IQ) report«document» Insurance police for parts shipment«document» Integration plan«document» Internet usage policy«document» Invention disclosure«document» Investigation site initiation«document» Invoice list«document» KPI Report«document» Label APPROVED«document» Label AUXILARY TEST TOOL-ID«document» Label COMPANY INVENTORY«document» Label CUSTOMER PROPERTY«document» Label DECOMMISSIONED«document» Label EQUIPMENT-ID«document» Label HANDLE WITH CARE«document» Label MEDICAL DEVICE«document» Label MODULE«document» Label NEXT CALIBRATION DATE«document» Label NEXT MAINTENANCE DATE«document» Label NEXT TSC«document» Label SPECIAL RELEASE«document» Label STATUS«document» Label STERILE MEDICAL DEVICE«document» Label SUSPENDED«document» Label TEST TOOL-ID«document» Label UNCONTROLLED WHEN PRINTED«document» Label USE FOR CLINICAL STUDY ONLY«document» Labeling instructions«document» Lieferantenhandbuch«document» List of critical components (electronic)«document» List of safety related components or modules«document» Listing and report of trained surgeons«document» Magazine library«document» Management review«document» Manufacturing instructions«document» Market research report«document» Medical Device Report (MDR)«document» Medical device book«document» Medical device summary report«document» Meeting Minutes«document» Module BOM«document» Module acceptance test instructions«document» Module acceptance test report«document» Module history«document» Module inventory«document» Module manufacturing instructions«document» Module manufacturing report«document» Module scrapping instructions«document» Module storage instructions«document» Morphological box«document» Non Disclosure Agreement (NDA)«document» Nonconfority and compaint report«document» Operational qualification (OQ) instructions«document» Operational qualification (OQ) report«document» Organisation chart«document» Overview assembling and testing«document» PCR-Product Change Request«document» PEMS Checklist«document» Packaging instructions«document» Packing list«document» Patent application«document» Patent family alert report«document» Patent family compilation«document» Patent family overview«document» Patient consent form«document» Patient insurance«document» Pension scheme«document» Performance qualification (PQ) instructions«document» Performance qualification (PQ) report«document» Prior Art documents«document» Probationary period staff report«document» Process qualification review report«document» Process-FMEA (PFMEA)«document» Product (clinical) validation plan«document» Product (clinical) validation report«document» Product (in-house) validation plan«document» Product (in-house) validation report«document» Product Requirement Specifications (PRS)«document» Product brochure«document» Product research report«document» Product roadmap«document» Production complete report«document» Production order«document» Production process«document» Production process instructions«document» Production staff instructions«document» Production statistics«document» Project plan«document» Purchase order«document» Purchase request«document» Qualification clinical investigator«document» Qualification investigation site«document» Quality and risk management plan«document» Quality assurance agreement«document» Quality audit plan«document» Quality audit report«document» Quality management planning«document» Quality objectives«document» Quality policy«document» RMA notice«document» Refurbishment report«document» Release for product development«document» Release for production«document» Repair list«document» Resource and budget plan«document» Review checklist DHA«document» Review checklist DHR«document» Review checklist DMR«document» Review checklist DRS«document» Review checklist ETF«document» Review checklist MHR«document» Review checklist MMR«document» Review checklist PRS«document» Review checklist SysRS«document» Review checklist USI«document» Review checklist applicable standards«document» Review checklist design FMEA«document» Review checklist industrial design«document» Review checklist issues«document» Review checklist labeling«document» Review checklist marketing materials«document» Review checklist mechatronic«document» Review checklist optical design«document» Review checklist process FMEA«document» Review checklist process validation«document» Review checklist product trainings«document» Review checklist project plan«document» Review checklist quality and risk management plan«document» Review checklist system integration«document» Review checklist tracing«document» Review checklist validation«document» Review checklist verification«document» Review report«document» Role assignment«document» Role description«document» SW Anomaly evaluation«document» SW Anomaly log«document» SW Architecture and integration plan«document» SW Change impact analysis«document» SW Classification (LOC)«document» SW Coding standards«document» SW Configuration management plan«document» SW Design specification«document» SW Document List«document» SW Guideline SOUP«document» SW Installation plan«document» SW Project plan«document» SW Release description«document» SW Release notes«document» SW Requirements specification«document» SW Review M1 (Design input)«document» SW Review M2.1 (Implementation)«document» SW Review M2.2 (Stabilization)«document» SW Review M3 (Verification)«document» SW Review M4 (Release)«document» SW Revision level history«document» SW Source code review report«document» SW Test procedure and report«document» SW Test summary«document» SW Traceability matrix«document» SW Verification plan«document» Safety architecture«document» Sales and service contract«document» Sales forecast«document» Sales order«document» Sales order backlog«document» Sales order confirmation«document» Sales quote«document» Sales report«document» Scope of Quality Management System«document» Search report of standards«document» Service manual«document» Service plan«document» Service report«document» Site survey«document» Spare part forecast«document» Spare part list«document» Stamp APPROVED«document» Stamp CONFIDENTIAL«document» Stamp INCOMING DATE«document» Stamp INVALID«document» Stamp QUOTE ASSESSMENT«document» Standard terms and conditions of business«document» Standard terms and conditions of purchase«document» Sterilization lot report«document» Stockturn report«document» Storage period for documents«document» Styleguide electronic development«document» Supplier audit plan«document» Supplier audit report«document» Supplier contract«document» Supplier order confirmation«document» Supplier profile«document» Supplier quote«document» Supplier rating«document» System Requirement / Use Specifications (SysRS/US)«document» System architecture«document» System verification plan«document» System verification report«document» TSC instructions«document» TSC test report«document» Template form sheet«document» Test report«document» Test tool auxilary list«document» Test tool borrowing report«document» Test tool calibration plan«document» Training Log«document» Training calendar«document» Training center excellence certificate«document» Training center performance report«document» Training center requirements«document» Training center training material«document» Training confirmation«document» Training content and training procedure plan«document» Training material«document» Travel plan«document» Travel policy«document» Usability Specification Inputs (USI)«document» User manual«document» Vacation list«document» Vacation requestSoftware toolsEquipmentFacilitiesProductsComplianceSandbox| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 25.02.2014 16:09:00 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Templates, Manage CAPA process, 7.4.1 Analyse changes to MEDICAL DEVICE SOFTWARE with respect to SAFETY, 7.4.2 Analyse impact of software changes on existing RISK CONTROL measures, Manage SOUP, Do Design-FMEA, Design History File |
