Over the past decade, the increased volume of medical devices on the market and the ever increasing technology embedded in these devices has driven the need for more specialized medical device design control consultants. \u00a0In today’s\u00a0world of complex software applications and hi-tech medical device designs, specialized design control consultants are invaluable for\u00a0the\u00a0interpretation of design control regulation that was introduced over two decades ago. Procenius consulting was formed to enable medical device manufacturers to find design control consultants that can meet their specific needs for interpreting and effectively implementing medical device design control regulation.<\/p>\n
Procenius’s medical device design\u00a0control\u00a0consultants\u00a0understand\u00a0the uniqueness of\u00a0today’s\u00a0<\/em>medical devices and\u00a0are experienced in a wide variety of medical devices.\u00a0Procenius’s services include an initial complimentary evaluation of our client’s needs to ensure requirements are identified upfront to ensure project goals are accurately addressed and completed on time.\u00a0Once requirements and project goals are established and the agreement is approved, consulting work will\u00a0be initiated.<\/p>\n Procenius’s medical device design control consultants will provide clear and accurate guidance and interpretation of design control regulation and how the regulations are applicable to the client’s products. Procenius specializes in helping medical device manufacturers understand how the regulation applies to their unique designs and development challenges.<\/p>\n Procenius medical device design control consultants will develop new design controls standard operating procedures (SOPs) or review existing SOP’s for regulation compliance. Procenius\u00a0will also develop (or assist manufacturers\u00a0in developing) streamlined and efficient procedures which encourage quality compliance.<\/p>\n Procenius can provide guidance or write development documentation such as design and development plans, design requirements, validation master plans, design history file records, protocols and reports, risk assessment plans and reports.<\/p>\n Procenius can also provide a quality compliance assessment of design control procedures and development documentation to ensure compliance to FDA regulation.<\/p>\n Procenius medical device design control consultants have extensive experience with practical implementation of design controls regulation for developing new design control processes or for making improvements to existing processes.<\/p>\nProcenius\u00a0Design Control and Risk Management\u00a0Consulting\u00a0Services Include<\/h1>\n
I. Regulation Guidance & Interpretation<\/h4>\n
II. SOP Development (Including product development life cycle design)<\/strong><\/h4>\n
III. Design and Development\u00a0Document\u00a0Preparation<\/strong><\/h4>\n
IV. Quality Compliance Reviews<\/strong><\/h4>\n
V. Practical Implementation Techniques<\/strong><\/h4>\n