Medical Device Design Control & Risk Management Consulting

(21 CFR 820.30 / ISO 13485 & ISO 14971)

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.  In today's world of complex software applications and hi-tech medical device designs, specialized design control consultants are invaluable for the interpretation 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.

Procenius's medical device design control consultants understand the uniqueness of today's medical devices and are experienced in a wide variety of medical devices. Procenius'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. Once requirements and project goals are established and the agreement is approved, consulting work will be initiated.

Procenius Design Control and Risk Management Consulting Services Include

I. Regulation Guidance & Interpretation

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.

II. SOP Development (Including product development life cycle design)

Procenius medical device design control consultants will develop new design controls standard operating procedures (SOPs) or review existing SOP's for regulation compliance. Procenius will also develop (or assist manufacturers in developing) streamlined and efficient procedures which encourage quality compliance.

III. Design and Development Document Preparation

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.

IV. Quality Compliance Reviews

Procenius can also provide a quality compliance assessment of design control procedures and development documentation to ensure compliance to FDA regulation.

V. Practical Implementation Techniques

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.

See Procenius's Principal Consultant Credentials