Are there patents on products or technologies that are very similar to your product/idea?Has organizational leadership approved of the product security policy and procedures?Have quality audit procedures been established and have quality audits been conducted?How do you build security into the life cycle of a medical device at a health system?How to best select an embedded software platform for next generation intelligent systems?Is the software device an accessory to a medical device that has a major level of concern?What approaches and tools may be leveraged in the design of a trustworthy medical device?What do you see as the greatest challenge facing the regulatory profession right now?What is the typical and maximum number of records retained on the device when in use?This IEC 62304 Guide is unlike books you're used to. If you're looking for a textbook, this might not be for you. This book and its included digital components is for you who understands the importance of asking great questions. This gives you the questions to uncover the IEC 62304 challenges you're facing and generate better solutions to solve those problems. Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department.Unless you're talking a one-time, single-use project, there should be a process. That process needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make IEC 62304 investments work better.This IEC 62304 All-Inclusive Self-Assessment enables You to be that person.INCLUDES all the tools you need to an in-depth IEC 62304 Self-Assessment. Featuring new and updated case-based questions, organized into seven core levels of IEC 62304 maturity, this Self-Assessment will help you identify areas in which IEC 62304 improvements can be made.In using the questions you will be better able to: Diagnose IEC 62304 projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices.Implement evidence-based best practice strategies aligned with overall goals.Integrate recent advances in IEC 62304 and process design strategies into practice according to best practice guidelines.Using the Self-Assessment tool gives you the IEC 62304 Scorecard, enabling you to develop a clear picture of which IEC 62304 areas need attention.Your purchase includes access to the IEC 62304 self-assessment digital components which gives you your dynamically prioritized projects-ready tool that enables you to define, show and lead your organization exactly with what's important.