FDA, Good Manufacturing Practices GMP, quality system, QSR, ISO 13485, regulatory consultants, manufacturing development device, drug, diagnostic, combination medical products, 510k, PMA, IDE
Example Documents
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When developing new systems or improving old ones, medical product companies and those allied with the medical product industry often ask us for example documents. On this web page for a nominal charge we provide examples of Quality Manuals, procedures, and forms frequently requested by our clients. From time to time we will remove some examples and add others.

The examples are in substantial compliance with relevant sections of the US and/or European regulations, however, The Tamarack Group does not claim or warrant that any document available here is in full compliance with any specific regulation. Documents brought into the company from an outside source should never be used to suit the unique needs of each operation. Our examples are useful for jumpstarting or benchmarking your documents.

Medical Device and Diagnostic Industry
Quality System Process Maps (VISIO format)
- Visio Quality System Process Maps  
Quality System Process Maps (PDF format)
- Quality Management Systems (QMS) Process Map  
- Documentation Control Process Map  
- Design and Development Process Map  
- Risk Management Process Map  
- Equipment Control Process Map  
- Production & Process Control Process Map  
- Purchasing Control Process Map  
- Change Management Process Map  
- Material Control Process Map  
- CAPA Process Map  
- Customer Feedback & Complaints Process Map  
- Customer Related Processes Map  
- Management Responsibility Process Map  
- Product Acceptance Process Map  
- Measurement Analysis & Improvement Process Map  
- Resource Management Personal Training Process Map  
Design Verification & Validation
- Design Verification / Validation Plan - Medical Devices  
Medical Device Labeling
- US Instruction for Use Labeling Review Checklist  
- US Package Labeling Review Checklist  
- US Promo and Advertising Labeling Review Checklist  
- EU IFU Labeling Review Checklist  
- EU Package Label Review Checklist  
Medical Device Labeling (MS Word format)
- US IFU Labeling Review Checklist  
- US Package Labeling Review Checklist  
- US Promo and Advertising Labeling Review Checklist  
- EU IFU Labeling Review Checklist  
- EU Package Label Review Checklist  

Pharma/Biotech
Risk Management
Product Risk Profile Article and Figures
- Product Risk Profiles Article  
- Figure 1 - Product Risk Profile  
- Figure 2 - Stages of Product Development and Deliverables  
- Figure 3 - Clinical Hazard Analysis Table  
- Figure 4 - Product Risk Assessment Table  
- Figure 5 - Severity Level Definitions  
Process Risk Profile Article and Figures
- Process Risk Profile Article  
- Figure 1 - Process Risk Profile Table  
- Figure 2 - Process Risk Assessment Table  
- Figure 3 - Process Risk Evaluation Categories & Risk Acceptability Criteria  
Product Requirements Documents Article
- Product Requirements Documents Article  
Risk Based Quality Management Systems Article
- Risk Based Quality Management Systems Article  

Combination Products