In collaboration with
ISO 13485 Foundation training teaches you the fundamentals of implementing and managing an ISO 13485 Medical Devices Quality Management System (MDQMS). You will be able to understand the various modules of an MDQMS during this training course, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review, and continuous improvement.
Fees
€380.00 per student exc. VAT
COURSE OUTLINES
Duration
Up to six months
Learning Objectives
This training course enables you to:
- Understand the elements and operations of a Medical Devices Quality Management System (MDQMS).
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks.
- Understand the approaches, methods and techniques used for the implementation and management of a MDQMS.
General Information
- Certification and examination fees are included in the price of the training course.
- PECB will provide training material of over 200 pages of information and practical examples.
- An attendance record worth 14 CPD (Continuing Professional Development) credits will be issued to participants who have attended the training course.
- In case of exam failure, the candidate can retake the exam once for free within 12 months of the initial exam date.
COURSE DETAILS
Course Agenda
Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485.
Medical Devices Quality Management System requirements.
Certification Exam
Examination
The “PECB Certified ISO 13485 Foundation” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:
Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS).Domain 2: Medical Devices Quality Management System (MDQMS).
PREREQUISITES
No prior knowledge is required
FEES & FUNDING
Through the Get Qualified Scheme, students benefit from tax credits of up to 70% of their course fees after successful completion. Our team can assist you with applying for the Get Qualified scheme when undergoing training at the NOUV Academy.
Businesses seeking to train their staff can benefit from the Investing in Skills Scheme, a government incentive designed to provide support to companies to increase the productivity and adaptability of individuals that are active in the Maltese labour market. Our team will assist you in accessing applicable schemes when enrolling your staff in training courses through the NOUV Academy.