Lifecycle Process for Medical Device Software

Implementation to Meet Regulatory Requirements

Course Objectives:

This program is designed to provide participants with a variety of knowledge and skills:

• Understand the European and FDA regulatory requirements (Medical Directive 2007/47/EC) regarding the development and validation of software
• Identify and understand relevant standards or useful guidance documents to declare conformity with regulatory requirements
• Understand how to implement quality management principles for development of medical device software.

Learn More

To get a detailed curriculum, find out scheduled locations or request this program in your area, contact LNE/G-MED America.

For an economical way to train multiple staff, ask us about an on-site program at your company.