Industry Expert Learning Series HRDF SBL Claimable
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.
COURSE OUTLINE 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 Validation & Clinical Evaluations
Risk Management & Usability/Human Factors Engineering in Medical Device Design
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 email@example.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