Design Controls for Medical Devices

FDA and ISO 13485 Compliance requirements that takes your device to the market without tears!

Course description

This course will give you a comprehensive walk-through of the regulatory requirements on development of medical devices. We discuss practical aspects related to the requirements and how development can be done in an effective way that also supports a safe and suitable product when on the market.

Course outline

  • Introduction and background
  • Specific challenges for combination products
  • Procedure(s) for design and development
  • Planning
  • Risk management
  • From user needs to Design Inputs
  • Design Output
  • Design Reviews
  • Design Verification
  • Design Validation
  • Design Transfer
  • Design Changes
  • Design History File

Learning objectives

  • Increase your understanding of both FDA requirements and the corresponding ISO 13485 paragraphs in combination with insight in the practical application of these requirements.
  • Understand the similarities and differences between FDA requirements and ISO 13485 requirements and also the relationship between design and development in ISO 13485 and corresponding requirements in MDR/IVDR
  • Being able to identify relevant aspects to evaluate during review or audit of design and development activities.

Who should attend

Individuals working with product and process development, product maintenance and Quality Assurance/Regulatory Affairs that needs comprehensive knowledge within the area. Also individuals working with internal or supplier audits will benefit from the content.


You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company’s internal quality assurance programs.
You should have at least 6-12 months experience of working with development and/or manufacturing of Medical Device products.


IndustryCombination products, Medical Device

Anna Sahlholm

Anna Lundén




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