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The following documents and samples are available for Sample Submissions.
(All templates are in digital form)

Click Templates below to expand the section and select the items you would like to purchase.
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Design Control Documents
Coding Guidelines $100.00

Proven guidelines that you can use as a basis for establishing or improving Coding Guidelines in your company.
Design and Development Procedures $100.00

Proven procedures that you can use as a basis for establishing or improving Design and Development procedures in your company.
SDD Guidelines $100.00

Proven guidelines that you can use as a basis for establishing or improving Software Design Description Guidelines in your company.
SRS Guidelines $100.00

Proven guidelines that you can use as a basis for establishing or improving Software Requirements Specification Guidelines in your company.
STP Guidelines $100.00

Proven guidelines that you can use as a basis for establishing or improving Software Test Procedure Guidelines in your company.
System Design and Development Plan $75.00

Proven plan that you can use as a basis for establishing or improving System Design and Development Plan in your company.
System Design Description $75.00

Functional example of a System Design Description that can be used as a basis for your product.
System Requirements Specification $75.00 Functional example of a System Requirements Specifications that can be used as a basis for your product.
System Test Report $75.00 Functional example of a System Test Report that can be used as a basis for your product.
System Validation Procedure $75.00 Functional example of a System Validation Procedure that can be used as a basis for your product.
User Manual $75.00 Functional example of a User Manual that can be used as a basis for your product.
Process Validation
Automated traceability tool and user manual $100.00 An automated traceability tool with user manual.
Final Acceptance Test Procedure $75.00 Proven procedures that you can use as a basis for establishing or improving Final Acceptance Test Procedures in your company.
Incoming Inspection Procedure $75.00 Proven procedures that you can use as a basis for establishing or improving Incoming Inspection Procedures in your company.
Process Validation Procedure $100.00 Proven plan that you can use as a basis for establishing or improving the manufacturing process in your company.
Sample IQ protocol $75.00 Functional example of an Installation Qualification that can be used as a basis for your process.
Sample OQ protocol $75.00 Functional example of an Operational Qualification that can be used as a basis for your process.
Sample Validation Master Plan $75.00 Functional example of a Manufacturing Validation Plan that can be used as a basis for your process.
Quality System Audits
ISO 13485 Inspection Checklist $75.00 Checklist for conducting ISO 13485 inspections to ensure compliance.
Product Review for Design Description $75.00 Checklist for conducting Product Reviews to ensure Requirements Specifications are being met.
Product Review for Requirements Specifications $75.00 Checklist for conducting Product Reviews to ensure Requirements Specifications are being met.
Product Review for Test Procedure $75.00 Checklist for conducting Product Reviews to ensure proper Test Procedures.
QSIT Inspection Checklist $75.00 Checklist for conducting QSIT Audits to ensure compliance with QSR.
QSR Audit Checklist $75.00 Checklist for conducting Quality System Audits to ensure compliance with QSR.
Quality System Procedure
CAPA Procedure $100.00 Proven plan that you can use as a basis for establishing or improving the CAPA process in your company.
Complaint Management Procedure $100.00 Proven plan that you can use as a basis for establishing or improving the CAPA process in your company.
Quality Manual $100.00 Proven plan that you can use as a basis for establishing or improving a Quality Manual in your company.
Safety Risk Analysis Procedures $100.00 Proven procedures that you can use as a basis for establishing or improving Safety Rick Analysis procedures in your company.
Quality System Training
Design Control Best Practices Presentation $125.00 Training presentation that covers best practices for design controls.
GAMP5 and Process Validation Presentation $125.00 Training presentation that covers GAMP5 and Process Validation.
QSR Training Presentation $125.00 Training presentation that covers Quality System Regulations.
Regulatory Submissions
510(k) Premarket Submission for FDA $150.00 This sample provides a functional example of a typical 510(k) submission.
Abbreviated 510(k) Premarket Submission $150.00 This sample provides a functional example of a abbreviated 510(k) submission.
Abbreviated 510(k) Submission Template $100.00 Proven template for use in an abbreviated 510(k) submission.
OIVD 510(k) Assay Only Submission Template $100.00 Proven template for use in an OIVD (Office of In Vitro Diagnostics) assay only 510(k) submission.
OIVD 510(k) Combination Submission Template $100.00 Proven template for use in an OIVD (Office of In Vitro Diagnostics) combination 510(k) submission.
OIVD 510(k) Instrument Only Submission Template $100.00 Proven template for use in an OIVD (Office of In Vitro Diagnostics) instrument only 510(k) submission.
Special 510(k) Premarket Submissions $150.00 This sample provides a functional example of a special 510(k) submission
Special 510(k) Submission Template $100.00 Proven template for use in a special 510(k)submission.
Technical File (CE Mark) Submission Template $100.00 Proven template for use in an OIVD (Office of In Vitro Diagnostics) assay only 510(k) submission.
Technical File for CE Mark $150.00 This sample provides a functional example of a typical CE Mark Technical File
Traditional 510(k) Submission Template $100.00 Proven template for use in a traditional 510(k) submission.
Safety Risk Management
Failure Modes and Effects Analysis $75.00 Functional example of a Failure Modes and Effects Analysis that can be used as a basis for your product.
Fault Tree Analysis $75.00 Functional example of a Fault Tree Analysis that can be used as a basis for your product.
Medical Device Directive Essential Requirements $75.00 This Checklist will help you control and establish directives for your Medical Device's essential requirements.
Medical Device Directives for Conformance Route Alt. $75.00 This provides a summary of the Conformity Assessment Procedure alternatives as defined in the Medical Device Directives, Council Directive 93/42/EEC of June 14, 1993, Article 11, concerning medical devices.
Risk Management Plan $75.00 Proven plan that you can use as a basis for establishing or improving Risk Management Plan in your company.
Safety Risk Analysis $75.00 Functional example of a Safety Risk Analysis that can be used as a basis for your product.
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