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SAULT COLLEGE OF APPLIED ARTS AND TECHNOLOGY SAULT STE. MARIE, ONTARIOCOURSE OUTLINE COURSE TITLE:Design History 2CODE NO. :ADV 228PROGRAM:Graphic DesignAUTHOR:Terry HillDATE:May 2011SEMESTER:PREVIOUS

How to fill out design history 2

How to fill out design history 2

1. To fill out design history 2, you need to follow these steps:
2. Start by gathering all the relevant information and documents related to the design project.
3. Begin by providing the basic project details such as the project name, client name, and project start and end dates.
4. Specify the design objectives and goals, outlining the desired outcome of the project.
5. Describe the design process, including the different stages involved in the project.
6. Provide a detailed explanation of the design concept, highlighting the main features and functionalities.
7. Document any alterations, revisions, or changes made to the original design concept.
8. Include a list of all the design team members involved, along with their roles and responsibilities.
9. Record any challenges or issues faced during the design process and how they were resolved.
10. Include any supporting documents, such as design sketches, mock-ups, or prototypes.
11. Finally, review and proofread the entire design history 2 document before submitting it for approval.

Who needs design history 2?

1. Design history 2 is typically needed by designers, design agencies, and project stakeholders.
2. It serves as a comprehensive record of the design project, documenting the progress, decisions made, and changes implemented throughout the process.
3. Designers can use it as a reference tool for future projects, while agencies and stakeholders can review it to assess the project's success and ensure compliance with design requirements.

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What is design history 2?

Design History 2 refers to a specific set of records and documentation required by regulatory agencies to track the design and development process of a medical device, ensuring that all design inputs, outputs, changes, and verification activities are properly documented.

Who is required to file design history 2?

Manufacturers of medical devices, particularly those seeking regulatory approval or compliant marketing, are required to file Design History 2 as part of the documentation needed to demonstrate their product's safety and efficacy.

How to fill out design history 2?

Filling out Design History 2 involves gathering and organizing all relevant design documents, including design plans, specifications, design reviews, and verification and validation activities, and compiling them according to the specified regulatory guidelines.

What is the purpose of design history 2?

The purpose of Design History 2 is to ensure that all aspects of the design process are documented and compliant with regulatory standards, thus ensuring safety, efficacy, and traceability of the medical device.

What information must be reported on design history 2?

Design History 2 must report information including design inputs, outputs, verification and validation results, design changes, and records of design reviews.