Procenius Consulting
About |
WHO WE ARE
Procenius Consulting is owned and operated by medical device professionals. We know the industry and we know what our clients need to be successful. We focus on helping medical device companies interpret and implement effective design control systems. We also focus on helping medical device professionals develop basic and advanced design control knowledge through design control training courses.
OUR BUSINESS OPERATIONS ARE BASED ON THESE VALUES
INTEGRITY: We put the highest value on being fair and honest with our clients, employees and suppliers. Our employees will maintain the highest level of integrity and fairness while performing all of their assignments.
HIGH QUALITY: We employ high quality professionals and we only accept high quaiity work to delight our clients.
CUSTOMER DELIGHT: We are not satisfied until our clients are completely delighted with our services.
WHO WE SERVE
We specialize in serving medical device manufacturers and professionals
We understand that the consulting and training needs for this industry is unique and have customized our consulting and training techniques to optimize the learning experience to effectively understand medical device regulation.
MEDICAL DEVICE DESIGN CONTROL CONSULTING (21 CFR 820.30)
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 design control consultants. In today's world of complex software applications and hi-tech medical device designs, specialized design controls consultants are invaluable for the interpretation of design control regulation that was introduced over two decades ago. Procenius design control 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'S 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.
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.
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.