Design Control - Your Ideas Consulting

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Design Control


Design Control (QSR 21 CFR Part 820/ ISO 13485)

This course is specifically adapted for the European audience.

Why do you need design control/ defined development processes?
Are these
invented by the regulatory authorities as a bureaucracy measure/ burden to punish development teams across the globe?
Discuss and explore the (real) root causes for the existence of development processes/ design control.

Medical device products with their development do own some or all of the following attributes:

  • high product design complexity

  • need for interfacing with humans efficiently when launched

  • containing safety relevant features

  • development requires an interdisciplinary team

  • teams are working together across the globe

The course content is directed to guide your team on a successful medical device product development:

  • predictable timelines

  • structured development approaches

  • using "best practice" and compliant processes in a scalable manner

  • the development processes interact appropriately

and to gain respective regulatory approval in addition.

Make sure your design process is compliant so you can avoid costly deviations. The FDA has identified design control as a key area in its QSIT top-down inspectional approach to proof compliance. According to the FDA, "Manufacturers must incorporate a set of checks and balances in their design processes to assure a safe, effective finished product." Learn about these requirements and how to control the design process to ensure that your devices meet the user needs.

Course Objectives for 2 days of training

Understand the reason for design and development processes and their role in the regulated medical device industry.

Learn about critical development processes and their interaction during in-depth discussions and workshops.
Explore the differences between US design control requirements/ perspective (21 CFR Part 820) and the European regulatory perspective (ISO 13485).


  • project phase and milestone model for product life cycle

  • design and development planning

  • design inputs and design outputs

  • design transfer

  • integration of risk analysis

  • corrective and preventive actions (CAPA)

  • teams and process ownership

  • postproduction information

  • compliant records/ design history file (DHF)

  • working with vendors

  • document control

Who Should Attend

All team members participating in an interdisciplinary medical device product development, responsible to built a robust compliant environment e.g. project management, system engineers; software, labeling, assay development, reagent/ instrument/ disposable manufacturing, service, quality assurance and regulatory affairs.

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