Two days workshop on
Medical Device Design Control
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Device design is critically important to bring safe, effective, and profitable devices to market. It is one of the most critical elements in your Quality Management System. Device design problems energized the US Congress to require FDA oversight of design, adding the requirements to the Quality System Regulation. Even today, many years after implementation, design control is one of the top problems cited in Warning Letters to device companies. Will your design control system pass your next FDA Inspection without any problems? The alternative is a Warning Letter.

Design Control in both QSR and ISO 13485:2003 can be complicated. Regardless of the complex structure, you need flawless execution. There are many concepts to understand and methods to implement for an effective and compliant system. FDA Investigators and Notified Body Auditors will ensure you have a successful system.

This workshop provides an opportunity to understand the issues and discuss them with your colleagues. It will help you learn the requirements, develop approaches, and execute them. Through examples and case studies you will solidify your understanding of design controls and learn how to develop procedures that define and document your approach. Many device manufacturers market in the US, the EU, and Canada - the workshop compares and contrasts the requirements to help you develop a comprehensive system. The workshop uses FDA’s Quality System Inspection Technique (QSIT) as a method to ensure correct implementation. In addition, the workshop makes use of many recent Warning Letters to illustrate potential problems and help you learn from the mistakes of others.

You will learn
Participants in this workshop will learn:
  • The regulatory basis for design controls in the US, the European Union, and Canada
  • Methods on design planning based on project management techniques
  • Developing sources of design input and resolving problems
  • The role of design output and methods to ensure it is complete
  • How to conduct design reviews that help improve the device design
  • Using design verification methods to match design output with design input
  • Conducting design validation and its critical elements of software validation and risk management
  • Implementing the five vital components of design change
Who Should Attend
  • Engineering Managers
  • Design Engineers
  • Production Engineers
  • Quality Managers
  • Quality Engineers
  • Regulatory Affairs Managers
  • Project Managers involved in design and development
  • Purchasing Managers
  • Purchasing Agents involved in outsourcing production or processes
Course Materials
  • Full slides from the PowerPoint presentations
  • A list of design control requirements and their regulatory source
  • A checklist for each required design control procedure
  • A copy of each interactive exercise worksheet
  • Reference documents:
    • FDA guidance on Design Controls
    • FDA Small Entity Compliance Guide on Design Controls
    • FDA guidance on Enhancements and Recalls
    • FDA guidance document on 510(k) changes
Agenda

Day 1 (8:00 a.m. - 9:00 a.m: Registration Process)

Part A - Statutory and Regulatory Requirements (9:00 a.m. - 10:15 a.m.)
  • Design Control
    • US - Food Drug and Cosmetics Act & 21 CFR Part 820
    • EU - Medical Device Directive (MDD) & EN ISO 13485:2012
    • Canada - Canadian Medical Device Regulations (CMDR) & ISO 13485:2003
  • Conformity Assessment Paths
    • US - Premarket Submissions
    • EU - MDD Annex II Technical Files & Design Dossiers
    • Canada - Medical Device License
  • Exercise - Identify Total Design Control Requirements
Break - 10:15 a.m. - 10:30 a.m.

Part B - Planning (10:30 a.m. - 12:00 p.m.)
  • Planning Stages
  • Interfaces
  • Project Management Techniques
    • Action List
    • Work Breakdown Structure (WBS)
    • Gantt Chart
    • Critical Path Method (CPM)
    • Program Evaluation and Review Technique (PERT)
  • Developing the Design History File (DHF)
  • Exercise - Developing a Project Plan
Lunch Break - 12:00 p.m. - 1:00 p.m.

Part C - Design Input (1:00 p.m. - 2:30 p.m.)
  • Requirements for the Procedure
  • Resolving design input issues (incomplete, ambiguous, or conflicting requirements)
  • Identifying the design input requirements
    • Performance
    • Functional
    • Safety
    • Regulatory
    • Market
  • Starting a trace matrix
  • Exercise - Developing and Resolving Input Requirements
Break - 2:30 p.m. - 2:45 p.m.

Part D - Design Outputs (2:45 p.m. - 4:30 p.m.)
  • Requirements for the Procedure
  • Total finished design output
    • The device
    • Packaging and labeling
    • Device Master Record (DMR)
  • Acceptance criteria
  • Essential product characteristics
  • Continuing the trace matrix
  • Exercise - Design Output Completeness
Session Wrap-up, End of Day One - 4:30 p.m. - 5:00 p.m.
Day 2

Part E - Design Review (9:00 a.m. - 10:15 a.m.)
  • Requirements for the Procedure
    • What needs to be covered
    • Who needs to attend
    • How to document results
    • Integrating risk management
  • Design Review at each Stage
  • Creating and Closing Action Items
  • Exercise - Identifying and Resolving Problems
Break - 10:15 a.m. - 10:30 a.m.

Part F - Design Verification (10:30 a.m. - 12:00 p.m.)
  • Requirements for the Procedure
  • Design Verification Tools
    • Failure Modes and Effects Analysis (FMEA)
    • Fault Tree Analysis (FTA)
    • Inspections and Tests
    • Document Review
    • Alternate Calculations
    • Similar Designs
  • The sample size question
  • Continuing the trace matrix
  • Exercise - Design Verification Methods
Lunch Break - 12:00 p.m. - 1:00 p.m.

Part G - Design Validation (1:00 p.m. - 2:30 p.m.)
  • Requirements for the Procedure
  • Initial Products or Equivalents
  • Defined conditions or simulation
  • Software Validation
  • Risk Management (ISO 14971:2007)
  • Usability Engineering
  • Continuing the trace matrix
  • Exercise - Examining a Design Validation Plan
Break - 2:30 p.m. - 2:45 p.m.

Part H - Design Transfer (2:45 p.m. - 4:30 p.m.)
  • Requirements for the Procedure
  • Process Controls, 820.70(a)
  • Purchasing Data, 820.50(b)
  • Process Validation, 820.75
  • Exercise - Determining When a Process Must be Validated
Part I - Design Changes
  • Requirements for the Procedure
  • Design change interrelationships — the five important considerations
    • When a production change is a design change
    • Does the design change create a new Device Identifier?
    • Does the design change require an updated 510(k)?
    • Does the design change impact the Risk Management File?
    • Is the design change an enhancement or a recall?
  • The design change flow chart shows the picture
  • Design change records
  • Exercise - Classify changes as a design change or a production process change
Session Wrap-up, End of Workshop - 4:30 p.m. - 5:00 p.m.
Description of the Exercises

Identify Total Design Control Requirements
Participants review specific design control requirements, determine their source, and identify implementation methods.

Developing a Project Plan
Participants analyze a small example project, identify stages, and develop a Work Breakdown Structure (WBS) and a Gantt chart for the project.

Developing and Resolving Input Requirements
Participants develop a set of design inputs for an example product and use the results to identify missing, incomplete, or ambiguous requirements.

Design Output Completeness
Participants review design outputs for an example product and identify essential requirements, acceptance criteria, and gaps in the requirements.

Identifying and Resolving Problems
Design reviews systematically examine a design to evaluate its adequacy and capability with the intent to identify problems. Participants critique a design review to determine if it is sufficient.

Design Verification Methods
Participants examine paired design inputs and design outputs and determine the best tool for design verification. In some cases the analysis is extended to look specific aspects of the tools.

Examining a Design Validation Plan
Participants critique a design validation that starts with user needs and intended uses. The plan uses production equivalents and simulated use conditions.

Determining When a Process Must be Validated
Some production processes require process validation, while others do not. Participants will determine analyze processes transferred to production and document whether they require process validation.

Classify changes as a design change or a production process change
QSIT informs the FDA Investigator that Production and Process Changes could be Design Changes. This exercise provides participants an opportunity to classify changes and provides insight into the decisions to make in the QMS.

Daniel O'Leary - President, Ombu Enterprises, LLC


Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.