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New FDA Design Control Training Courses

03-08-2017 11:22 AM CET | Health & Medicine

Press release from: Procenius Consulting

Salt Lake City, Utah - February 23 2017 - Procenius Consulting is a medical device consulting firm specializing solely in medical device design controls regulation (21 CFR 820.30).

Announcing New Design Control Training Courses
Procenius Consulting has just launched two new training courses covering basic and advanced topics of medical device design control regulation. These courses focus on compliance, practical implementation and industry best practices techniques for developing or improving a streamlined and compliant design control product development system.

Procenius offers two design control training courses (basic/intermediate and intermediate/advanced) to meet the needs of medical device professionals at all skill levels and experience:

Basic/Intermediate Course
This design controls training course is 2.5 days of intensive workshop instruction which provides an in depth analysis of all design control regulation concepts (21 CFR 820.30), industry best practices, and methods for how design controls should be implemented into a medical device manufacturer's quality system. This course provides real life examples and case studies which are designed to solidify regulation concepts with practical application. The focus of this design control training course is to emphasizes how design controls are applied throughout the development process and after production release.This workshop is appropriate for medical device professionals with minimal to moderate experience with design control regulation. This course uses a unique blend of instruction from industry experts and resources from FDA regulation and guidance.

Advanced Course
This 2-day design controls training course provides an in depth and advanced review of four of the core design control topics: design validation, design verification, risk management and design inputs. Day 1 will be a deep dive into understanding the four core topics that will be evaluated using the regulation, FDA guidance, examples and cases studies to provide attendees with a solid background in these areas. Day 2 will be an all day, hands on case study workshop where the class will be developing a device from user needs and will be concluding with final design validation.

This design controls training course will provide a greater understanding and appreciation for design control regulation, standards and best practices. This course is designed for medical device professionals that are involved in performing, developing, or reviewing design validation / verification, design requirements, or risk analysis protocols, reports, strategies or plans. This course will demonstrate advanced techniques for applying the regulation efficiently during the development process. This course is appropriate for medical device professionals with moderate to advanced experience with design control regulation (or has attended the Basic/Intermediate workshop).

Consulting Services Expanded
Procenius consulting also has expanded its consulting services to include risk management and process validation consulting to complement the design control consulting offering.

Complimentary Hand Book
Procenius Consulting now provides a complimentary copy of:​ Design Control, Risk Management and Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation. with all consulting and training services
FDA Regulation Cross Referencing
Project Management Integration
Practical Best Practices & Templates
Case Studies & Examples
Regulation, Guidance and Preamble Included
​​​​440+ Pages (8.5 X 11)
Design Controls (21 CFR 820.30)
Risk Management (ISO 14971)
Process Validation (21 CFR 820.75)​

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.

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.

Procenius Consulting
1500 400 East
Salt Lake City, Utah

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