How do you use design control software to track and document design changes?

1 Why track and document design changes?

Design changes are inevitable in any medical device project. You may need to modify your design to address user feedback, technical issues, regulatory requirements, or market opportunities. However, design changes can also introduce risks, errors, or inconsistencies that can compromise your product's performance or safety. Therefore, you need to track and document design changes to ensure that they are justified, approved, implemented, verified, and validated. Tracking and documenting design changes also helps you to demonstrate that your design meets the specifications and standards that you defined in your design plan and design input.

2 How to track and document design changes?

Design control software is a software application that helps you to track and document design changes in a systematic and traceable way. It enables you to create, review, approve, and store design change records that capture the details of each change, such as the reason, scope, impact, date, and responsible person. Design control software also allows you to link design change records to other design documents, such as design output, design verification, design validation, risk analysis, and design review. This way, you can easily trace the origin and effect of each change, and ensure that all relevant documents are updated accordingly.

3 What are the benefits of using design control software?

Using design control software to track and document design changes can offer multiple advantages for your medical device project. This includes improving the quality and consistency of your design documentation, as well as enhancing collaboration and communication amongst design team members. Additionally, it can facilitate the management and oversight of the design process, while supporting compliance and auditability of design activities. Moreover, it allows you to deliver a safe and effective design that meets customer needs and expectations, increasing customer satisfaction and confidence in your product.

4 How to choose the right design control software?

When selecting design control software for your project, there are many factors to consider, such as the size and complexity of your project, the type and scope of your design changes, the level and format of your design documentation, the budget and resources that you have for purchasing and implementing the software, and the customer and regulatory requirements that you need to comply with. Additionally, you should consider the number and diversity of your design team members, the frequency and urgency of your design reviews and approvals, the integration and compatibility with other software tools or systems that you use, and the level of support and training that you need from the software provider.

5 How to use design control software effectively?

To use design control software effectively, you need to define and document your design control process and procedures, aligned with your design plan and design input. Educate your design team members on how to use the software and establish clear roles and responsibilities for each design activity. Consistency is key, so avoid using other tools or methods that may cause confusion or inconsistency. Regularly review and update your design documents to ensure accuracy, and use the feedback and data from the design control software to identify and implement improvements. Additionally, monitor and evaluate your design performance and quality.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?