Med Tech Product Realization
Quality System Consulting
Compliance to the regulations is mandated. How you achieve that compliance can make or break your business performance. Our focus is to help you connect compliance to profitable growth.
We help you to meet and apply the regulations in a compliant, effective, and efficient manner.
Our experience within the Med-Tech industry includes Devices for Cardiology, Dialysis, Pulmonary Combination Products, Minimally Invasive Surgery and Robotic Assisted Surgery.
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Compliant
Learn how to develop procedures that support compliance to regulations.
Effective
Learn how to execute those procedures in a manner that supports device effectiveness.
Efficient
Learn how to improve execution and reduce waste.
What can we do for you?
Consulting
Our focus is on helping you in designing product development processes that are compliant, effective and efficient.
Courses
We provide a number of courses that can be given on site or virtually. They cover three of the major topics within product realization; Risk Management, Design Control, and Production and Process Control.
LATEST From Our Modules
Level Up Your Understanding of Product Realization
Our modules have everything you need to better understand product realization and the components necessary to maximize profits and minimize risks.
Pre-Register for our Mastering Design Control Webinar!Introduction
Nice to meet you!
Hi, my name is Laurence Keane and I am the founder of PxP Consulting LLC. I have worked more than 30 years in the medical device industry, and held roles as Vice President of Quality and R&D Engineering Systems within a Fortune 500 company.
I have had the honor of leading and being part of teams that have consistently delivered multi-million dollar product-cost savings, reduced customer complaints, and realized successful quality system inspections. I now work with leadership and their teams to establish and implement product realization quality systems.
Our vision for you is that the processes we develop with you are easy to teach, learn, and use; and compliance is integrated and seen as a game changer for your company. I invite you to contact me or sign up for one of my courses. I look forward to discussing your medical device process development, and how PxP Consulting LLC may serve you in reaching your goal of connecting compliance to profitable growth.
I invite you to contact me or sign up for one of my courses.
Check out our Courses!
"Working with PxP made it easy to understand and implement design controls in a manner that brought our teams together."
- Vice President of Operations, Medical Device Company
"PxP listened to what I wanted rather than telling me what I needed, they created a win win environment."
- Vice President of R & D, Medical Device Company.
"PxP held the vision constant and helped us navigate beyond our ingrained habits to a new more effective process!"
- Director of R & D, Medical Device Company.
ONLINE COURSES
The Product Realization Academy
Take control of your product realization compliance processes with these comprehensive courses.
Mastering Design Control
A crash course in understanding Design Inputs vs Outputs
Mastering Risk Management
A crash course in the foundations of Risk Management compliance
Mastering Production and Process Control
A crash course in the foundations of production and process control compliance
Mastering Product Realization
Realize your products the right way, through compliance and team collaboration.