MEDICAL DEVICE QMS & REGULATORY COURSE
 PLEASE book by 6th JUNE 2016 |
MEDICAL DEVICE QMS & REGULATORY COURSE
Assuring your company’s regulatory compliance for imminent South African regulations … 27th JUNE to 1st JULY2016 (JHB) .. Capetonians and Durbanites please email info@r-sctraining.co.za if interested in a course in YOUR AREA
With the pending DOH Medical Device & IVD Regulations and guidelines this COURSE will let you know and understand the requirements and approach of medical device regulations, a quality management system and ISO13485 User, Patient and Product safety risk assessment, Documentation with Procedures and Records controls and internal auditing of a quality management system
Day 1: Introduction to ISO 13485 management system
What is a medical device, Quality Management system Process, Corrective and Preventive Action?
Product Safety, Role Players and Legislation, Regulations, classification, Essential Principles, Safety & Performance, Clinical Evaluation
DAY 2; ISO14971 Risk Management system; Risk analysis, Risk evaluation & Risk control, Risk management report, Post-production information
Day 3-4; ISO 13485 Management System review
Organization, Management System, Management Review, Document & Record Control, Contracts & Services, Complaints, non-conformance handling, Data Analysis, Continual Improvement, CAPA & Continual improvement
Day 4-5 Internal Auditing concepts and practical coverage of the auditing process for the planning, preparation, practice, reporting and follow up
Who Should Attend?
Quality and regulatory professionals, engineers, designers and managers, that have ISO9001 understanding and/or training, that need to know and understand the requirements for ISO 13485 quality systems, regulatory requirements and ISO 14971 Risk Management
Venue: Johannesburg (Shimadzu offices, Honeydew)
Price: full 5 days R10950.00 (5% Discount if PAID BY 6th JUNE 2016)
All prices exclude VAT @ 14%, Travel & Accommodation. payment required 2 weeks prior
Go to …. www.r-sctraining.co.za
OR CONTACT info@r-sctraining.co.za
