It is important that engineers document the design process so that they can communicate it to others and ensure no information is lost. It is also critical for convincing decision-makers to approve ...

Planning ahead for design transfer and using it as a management tool results in a smoother, less costly transition from development to production. Terry Zenner It has become popular to say that all ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

It is the job of the Process Design Kit (PDK) engineers to deliver a high-quality PDK that properly represents the process requirements and constraints and supports the design flows used by their ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

Testing an AI agent for donor tissue screening at Evergen surfaces more than technical performance questions. The project ...

People often confuse the purpose and role of functional specifications and design documents. Design and function should never meet in a document. Design and function must be documented during the ...

Microsoft Office tools, and in most cases Visio, are ubiquitous in the Windows environment. So, it is not surprising that tools such as Excel, Word, PowerPoint, Outlook, and Internet Explorer have ...

Do you need a design or functional specification? It depends on who your audience is and where you are in the product development cycle. People often confuse the purpose and role of functional ...