(Customer)

Product Requirements Document

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Product Requirements Document (PRD) (Product Name)

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Product Requirements Document 1. Product Description
1.1 Summary

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1.2

Intended Use

1.3

Theory of Operation

2.

Design Input
1.1 Marketing input

1.2

Sales input

1.3

Customer needs and requests (can be from market surveys, focus groups, questionnaires)

1.4

Customer complaint files for existing relevant products

1.5

Competitive product comparisons (requirements inferred from competitive products)

1.6

Company Medical Device Reports

1.7

Competitive Medical Device Reports

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(Customer)
Product Requirements Document 3. Reference Standards

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4.

Functional Requirements
3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 Physical Characteristics Material Requirements Electrical Requirements Abilities Limitations Equipment or materials required to use the product Equipment interface requirements Handling and storage requirements Cleaning and Sterilization Re-use Disposal Product maintenance and serviceability

5.

Environmental Conditions
4.1 Temperature 4.1.1 Operating: 4.1.2 Storage: Humidity 4.2.1 Operating: 4.2.2 Storage: Shipping, transportation vibration Pressure and Altitude

4.2

4.3 4.4

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(Customer)
Product Requirements Document
4.5 4.6 4.7 Electromagnetic Interference Electrostatic Discharge Impact Resistance

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6.

Performance Requirements
5.1 5.2 5.3 5.4 Operating parameters Repeatability and reproducibility Reliability Shelf life and Stability

7.

Safety
6.1 6.2 6.3 6.4 6.5 Biocompatibility Potential or anticipated misuses Requirements to reduce user induced failure Mechanical safety features Electrical safety features

8.

Human Factors
7.1 7.2 7.3 User interface Ergonomics Training or skills required

9.

Manufacturing
8.1 8.2 Key processes and controls Lot size and quantity per month CONFIDENTIAL

(Customer)
Product Requirements Document
8.3 8.4 8.5 8.6 Cost Environmental requirements for production Raw materials and suppliers Test methods, standards

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9.

Packaging
9.1 9.2 9.3 Packaging configurations Packaging materials Special shipment requirements

10.

Labeling
10.1 10.2 10.3 Detail intended use, warning, directions for use, cleaning, expiration date Identify target audience for labeling Language requirements

11.

Regulatory
11.1 11.2 11.3 11.4 11.5 11.6 Clinical trials Submission type CE mark US and international standards Patent issues Existing technology to avoid

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