Introduction to Essential Principles of Safety and Performance in Medical Devices
DURATION : 1.5 days
INTRODUCTION
This course provides participants with an understanding of the requirements in relation to the safety and performance characteristics of Medical Devices intended to satisfy medical device regulatory requirements. Participants obtain an understanding of General Principles as well as the Particular Principles adopted under a harmonized approach, thus enabling the collation of data needed for medical device product approval and registration.
Participants will be led by an accomplished tutor with over 2 decades of practical experience in the subject matter gained from auditing, training and quality assurance as well as management system development activities. Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed. The course is designed to ensure participants understand the requirements for the successful collation of evidence of compliance to these Essential Principles.
COURSE OBJECTIVES / OUTLINE
This course provides a holistic approach toward the following essentials
1. General Principles
2. Chemical, Physical & Biological Properties
3. Infection & Microbial Contamination
4. Construction & Environmental Properties
5. Medical Devices with a Measuring Function
6. Protection against Radiation
7. Medical Devices Equipped or Connected with Energy Source
8. Information to be provided with Medical Devices
9. Clinical Evidence
INTRODUCTION
This course provides participants with an understanding of the requirements in relation to the safety and performance characteristics of Medical Devices intended to satisfy medical device regulatory requirements. Participants obtain an understanding of General Principles as well as the Particular Principles adopted under a harmonized approach, thus enabling the collation of data needed for medical device product approval and registration.
Participants will be led by an accomplished tutor with over 2 decades of practical experience in the subject matter gained from auditing, training and quality assurance as well as management system development activities. Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed. The course is designed to ensure participants understand the requirements for the successful collation of evidence of compliance to these Essential Principles.
COURSE OBJECTIVES / OUTLINE
This course provides a holistic approach toward the following essentials
1. General Principles
2. Chemical, Physical & Biological Properties
3. Infection & Microbial Contamination
4. Construction & Environmental Properties
5. Medical Devices with a Measuring Function
6. Protection against Radiation
7. Medical Devices Equipped or Connected with Energy Source
8. Information to be provided with Medical Devices
9. Clinical Evidence
TARGET AUDIENCE
PRE-REQUISITE
Basic knowledge of medical devices would be beneficial.
iNTERESTED TO FIND OUT MORE?
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347
- Regulatory Personnel
- Quality System Auditors
- Management representatives
- Policy Makers
- Supply Chain Managers & Auditors
PRE-REQUISITE
Basic knowledge of medical devices would be beneficial.
iNTERESTED TO FIND OUT MORE?
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347