Procenius Consulting

Procenius provides design controls consulting and training for start-ups, midsize and major medical device manufacturers. Procenius specializes in helping medical device manufacturers interpret FDA regulation and implement practical design and development processes to ensure quality compliance. DESIGN CONTROL TRAINING Procenius also offers specialized, in depth, design control training courses for the practical implementation of medical device regulation. The training includes medical device regulation review and case study review. DESIGN CONTROLS CONSULTING SERVICES INCLUDE | Regulation Guidance & Interpretation | Procenius 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. | SOP Development (Including product development life cycle design) | Procenius 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. | Quality Compliance Reviews | Procenius can also provide a quality compliance assessment of design control procedures and development documentation to ensure compliance to FDA regulation. | Practical Implementation Techniques | Procenius consultants have extensive experience with practical implementation of design controls regulation for developing new design control processes or for making improvements to existing processes.

• Employees 0
• Founded 2014