Medical
/// Medical device manufacturers
ENGLISH
INTRA
Medical device software life cycle processes
How to meet regulatory requirements
Medical device manufacturers
• Quality assurance managers
• Regulatory Affairs managers
• R&D managers
• Software platform developpers
• Know the European (Medical
Directive 2007/4/EEC) and US (FDA)
regulatory requirements related to
the development and validation of
software
• Identify and adopt the normative
documents or useful guides to declare
software compliance with regulatory
requirements
• Namely to implement the principles
of quality management for the
development of a medical device
software
PREREQUISITES
• Basic knowledge of quality management principles and the fundamentals of the risk
management process
MATERIALS AND TEACHING RESOURCES
• Presentation Slides
• Case studies
• Full binder with presentation slides
• Session survey
• Breaks and lunches with all participants to share experiences and learnings
Note: exercises are documentary manner over the two days
ADVANTAGES
•S
kills of the trainer
•R
eturn of experience from past
audit
EVALUATION PROCEDURES
• This training does not lead to a formal assessment
• A customer satisfaction questionnaire is given at the end of the training
CONTENT
DAY 1 /// 9 : 30 AM - 05 : 30 PM
• Welcome and Opening
• Regulations: the regulations concerning the development and validation of software
• Overview of US and European requirements
• Presentation of standards and guidelines made available to manufacturers
to meet regulatory requirements
• Development planning software
• Requirements definition (system input data)
• Design and development of software
Course director
and Keynote speaker
Julien SZCZESNIAK
Certification project manager
G-MED certification division
Certification and Standards
Department - LNE
DAY 2 /// 9 : 00 AM - 5 : 00 PM
• Implementation of a risk management process applied to software
• Testing of the software
• Configuration management and cybersecurity
• Software maintenance and resolution of software related problems: how to implement
a process of corrective and preventive actions?
• Discussion, conclusion, assessment of training
Reference
SA 36
2 DAYS /// 14 HOURS
CONTACT US
LABORATOIRE NATIONAL DE MÉTROLOGIE ET D’ESSAIS - CENTRE DE FORMATION
Tél. : 01 40 43 37 35 - Fax : 01 40 43 37 37 - [email protected] - www.lne.fr
2017
M E D IC A L
AUDIENCE
GOALS