Overview of regulatory affairs for medical device
Course Outline:
This two months training program provides the exposure towards the healthcare growing industry
with its dynamic approach. From the idea of making a device to commercializing, professionals need
a strong knowledge of the process and the regulatory authorities who are involved in developing
such systematic approaches. In this course, students will be able to grab the concepts behind the
regulation of medical devices and market of EU. This course is designed for the individuals, who are
keen to pursue their career in medical devices, quality, bioengineering and marketing. After this
course, you will be able to gain the practical skills of life cycle of product, its inspection and
coherence with the regulatory authorities.
SCHEDULE:
1st Month
Week 01 (3 hours)
Lecture (01)
o Introduction
o Key Trends in medical device industry
o Role of regulatory affairs during different stages of Product life
Lecture (02)
o History of Medical Devices & evolution of regulatory affairs
o Biomedical Market Environment
Week 02(2.5 hours)
Lecture (01)
o Market Strategic Challenges for Medical Device
o Market Analysis and Evaluation
o Challenges in the market
Lecture (02)
o Medical Device Classification
Week 03(3.5 hours)
Lecture (01)
o Regulatory Specialists in Medical Devices in Europe
o Medical Device Safety and Related ISO Standards
Lecture (02)
o Quality Management system as a requirement
Week 04(3 hours)
Lecture (01)
o Risk Management to medical devices
o Processing of RM
Lecture (02)
o IEC International Standard
o Conformity Assessment for medical devices
2ND Month
Week 01 (3 hours)
Lecture (01)
o European Union Medical Device Regulatory System
o Classification of new medical device regulation
Lecture (02)
o Technical documentation
Week 02 (4 hours)
Lecture (01)
o QMS of new regulatory systems
o Risk management by EU system
Lecture (02)
o Clinical evaluations
o Certification
Week 03(3 hours)
Lecture (01)
o Post-Market Surveillance
o MDD to MDR
Lecture (02)
o Follow ups and risk reviews
o State and federal site inspections
Week 04(3 hours)
Lecture (01)
o Universal Device Identification
o International Marketing
Course Designed by:
Engr. Fozia Zafar
Biomedical Engineer
Course Designed For: GREEN BIOTEC Academy
