Medical Device Design Control
INTRODUCTION
This course examines the basic elements of regulatory requirements on medical devices and discusses examples of what systems are needed to be in put in place in by medical device manufacturers.
Participants will gain an understanding of areas of focus (as well as areas of common non-conformity/ non-compliance by manufacturers) by ISO 13485 CAB auditors and US FDA plant inspections.
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.
COURSE OBJECTIVES
The course is designed to ensure participants understand the requirements for the successful collation of evidence of compliance on design & development of medical devices.
This course examines the basic elements of regulatory requirements on medical devices and discusses examples of what systems are needed to be in put in place in by medical device manufacturers.
Participants will gain an understanding of areas of focus (as well as areas of common non-conformity/ non-compliance by manufacturers) by ISO 13485 CAB auditors and US FDA plant inspections.
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.
COURSE OBJECTIVES
The course is designed to ensure participants understand the requirements for the successful collation of evidence of compliance on design & development of medical devices.
COURSE OUTLINE
This course provides an in depth understanding of medical device design & development requirements and associated essential areas:
TARGET AUDIENCE
• Regulatory Personnel
• Quality System Auditors
• Management representatives
• R & D staff
• Risk Management Team members
PRE-REQUISITES
Basic knowledge of medical devices and quality systems would be beneficial.
DURATION
Two (2) full days
CONTACT
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
This course provides an in depth understanding of medical device design & development requirements and associated essential areas:
- Medical Device Development Process & Planning
- Design Input & Risk Management Output
- Design Output & Reviews
- Design Verification
- Design Validation & Clinical Evaluations
- Change Control
- Design Transfer
- Risk Management & Usability/Human Factors Engineering in Medical Device Design
- Technical Documentation -- DHF’s & Design Dossiers
- The role of Standards
- Clinical Evaluation
- Design Control -- Quality Systems, ISO 13485, 21 CFR 820 & GMP
TARGET AUDIENCE
• Regulatory Personnel
• Quality System Auditors
• Management representatives
• R & D staff
• Risk Management Team members
PRE-REQUISITES
Basic knowledge of medical devices and quality systems would be beneficial.
DURATION
Two (2) full days
CONTACT
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