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Benefits to you

Design control overview

This course provides you with an overview of the regulatory framework that applies to both EU and US and helps you understand design control.

What standards apply?

You cannot complete a medical device product development project without taking standards into consideration. The course will reference and introduce you to the most common standards that needs to be considered when designing medical devices, for example ISO 14971, IEC 62366, IEC 60601-1 and ISO 10993-1.

Be active

We pride ourselves in not making too many bullet points and having an active teaching style with lots of interactivity. The course has a learning goal and every section is followed up to ensure effective learning. You will be awake.

Course program

Day 1

  • Introduction
  • The regulatory framework
  • Standards
  • Documents and records
  • The product approval process
  • Audits and Compliance
  • Key elements of design control
  • Product development phases and design control
  • Design planning
  • Documentation pitfalls

Day 2

  • Design and development inputs
  • Organisational planning
  • Design review
  • Risk management and EN ISO 14971
  • Usability and EN 62366
  • Design output
  • Design transfer
  • Design verification and validation
  • Design release
  • Change control

Would you prefer a course held on your premises?

We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

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Register for a course

If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.

Register for a course

Enter your details below to request more information about our professional courses in medical device product development. Or simply call us on +46 708 186 800