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Design Control - Quality Assurance in Product Development

"I feel that the very knowledgeable and experienced instructor gave me a very comprehensive insight in the most important fields of Design Control. Both when we talked about the Medical Device Design Control process and also fulfilment of the requirements from FDA and other regulatory authorities" Participant, May 2011


Who should attend?

This course will be geared to members of product design teams and their support organizations from any function within the company who actively participate in the development, documentation or regulatory requirements of bringing a new or revised device to market.    This may include people who audit design control functions, as well as those who perform these functions.  Product Development/R&D, Manufacturing, QA, and Regulatory personnel all will benefit from this practical experience in managing the design control function. 


Course benefit

The course provides a practical approach to how and when to comply with the US and EU regulatory requirements for the design and development of new devices.  Practical workshops will assist in developing a clear method of developing some of the major required documents, from design inputs, to risk analysis and the design history file.  Emphasis will be on understanding the process enough to use better judgment for what and how much needs to be done.


Course content

During the course we will review the regulatory documents that apply and will spend time performing some class activities to make the regulations practical.  We will also create a model for a design control process that is intended to make the process go smoothly and with less setbacks.  We will cover all the main areas of the requirements including design inputs, plans, outputs, risk analysis, verification and validation, the DMR, the DHF, when design transfer occurs, and how to manage later design changes.


As we go through the process with practical examples, we will discuss the documentation to be created for successful new product applications to regulatory authorities.  We will also spend some time discussing case studies where the process has not gone well.  Attendants will be encouraged to bring their own procedures and any documents they feel they need help with or can be openly discussed.  

Course language

The course will be conducted in English. 



Medicoindustrien | Forskerparken Scion DTU | Agern Allé 13 | DK-2970 Hørsholm | E-mail: | Phone +45 4918 4700