• Type

  • Focus Area

Interactive Guide 1 – 1

1.1. Design Project Plan The Design Project Plan identifies and describes the specific plan for the design and development activities to be performed including a proposed timeline with projected milestones. The plan includes proposed quality practices, assessment...

Interactive Guide 1 – 2

1.2. Establish Product Description/Specifications/Labeling A formal description of the proposed product and design requirements based on customer requirements determined from a variety of sources including customer feedback, formal or informal customer surveys,...

Interactive Guide 1 – 3

1.3. Risk Management  Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk.[dsm_advanced_tabs dsm_tabs_bg_color="rgba(255,255,255,0.3)" dsm_tabs_text_color="#141414"...

Interactive Guide 1 – 4

Validation Master Plan  A macro-level plan that identifies all the activities to be undertaken to assure the device design, equipment and quality system process(es) consistently produce devices that meet the formal design input requirements.[dsm_advanced_tabs...

Interactive Guide 1 – 5

1.5. Regulatory Compliance Process of ensuring that a medical device meets all applicable regulations, standards, and guidelines set by regulatory bodies such as the U.S. FDA, European Notified Bodies, etc. These regulations are in place to ensure the safety,...