Design Control

Participants will acquire basic knowledge on how to work with product development in an organisation where design control requirements apply.

Introduction
This two day course focuses on how to develop new products and maintain them in an organisation in which design control requirements apply. The course addresses what level of documentation is required and provides tools on how to work successfully and effectively with design control. Since standards play an important role in design control and developing medical devices, the course introduces the most commonly used standards that usually apply to development. This includes ISO 14971 on risk management, IEC 60601-1 on electrical safety and IEC 62366 on usability. The delegates will also learn about the most common pitfalls in medical device product development. The course covers both US and EU requirements. 
 
The course is targeted towards professionals involved in:

  • Development of medical devices
  • Meeting design control requirements (such as those in quality assurance)
  • Project management
  • Design engineering
  • Members of research and development or new product development teams

Course benefit 
Participants will acquire basic knowledge on how to work with product development in an organisation where design control requirements apply.
 
Course form
The course consists of a mixture of lectures, workshops and discussions. The instructor will follow up on learning objectives throughout the course, meaning that participants continuously will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance is required to be eligible for course certificate.
 
Course language
The course will be conducted in English. 
 
Instructor
Peter Sebelius, Gantus AB

"The presenter was excellent in maintaining interests over two very intensive days conveying a lot of information in a very big field"

Participant, November 2015

Kontakt

Morten Petersen
Kursuskoordinator
49184703