ISO 13485:2016 MDQMS

Course Overview

The ISO 13485:2016 Medical Devices Quality Management System (MDQMS) course provides comprehensive guidance on the requirements for quality management systems specific to the medical device industry. This standard outlines the necessary processes and controls to ensure the consistent design, development, production, installation, and servicing of medical devices while meeting regulatory requirements. The course covers key topics such as risk management, design and development validation, production and process controls, and regulatory compliance. Participants will gain a deep understanding of the ISO 13485 standard and learn practical strategies for implementing and maintaining an effective MDQMS within their organizations.

Course Duration:

The duration of the ISO 13485:2016 certification is one week that includes practical exercises, case studies, and preparation for certification exams or assessments.

Who Should Enroll?

This course is ideal for quality assurance managers, regulatory affairs professionals, medical device manufacturers, suppliers to the medical device industry, auditors, and consultants seeking to enhance their understanding and proficiency in medical device quality management.
Whether you’re involved in the production, distribution, or servicing of medical devices, enrolling in this course can help you ensure compliance with regulatory requirements, improve product quality and safety, and enhance customer satisfaction.

Assessment Method

The assessment method for the “ISO 13485:2016 MDQMS” qualification involves a written exam. To be awarded this qualification, learners must achieve a percentage pass in the written exam.

This ensures that participants have demonstrated a comprehensive understanding of ISO principles and are proficient in applying them in various contexts

The written exam rigorously evaluates participants’ knowledge of key concepts, while the overall assessment encompasses a broader range of skills and competencies related to ISO 13485:2016 MDQMS.

The exam is graded out of a total of 100 marks, and a passing score requires a minimum of 45 marks.

Why Choose IACP UK?

Speed and Reliability: At IACP, we prioritize efficiency and consistency. Our assessment materials and documentation are provided at no additional cost upon registration, reflecting our commitment to seamless service. With a streamlined process, we deliver results and certificates promptly, outpacing industry standards. We take pride in our responsive customer support team, ensuring that inquiries are addressed within 24 hours.

Popularity and Trustworthiness: IACP’s courses and qualifications enjoy widespread popularity and trust. They are delivered by approved centers globally, including schools, employers, prisons, and private training providers. Our courses transcend traditional education boundaries, making them accessible and relevant to various community settings.

Dedicated Account Management:When you choose IACP, you’re paired with a dedicated and knowledgeable account manager. This personalized approach ensures that your needs are met with tailored solutions and prompt assistance.

Experience and Expertise: With over 100 years of combined experience, our team is highly skilled in developing, designing, and delivering training courses at various levels. Our reputation for excellence is built on a foundation of expertise and credibility in the education and assessment sector.

Comprehensive Training Solutions: As a one-stop shop for training solutions, IACP offers a comprehensive range of courses and qualifications. Our commitment to quality, reliability, and depth of knowledge sets us apart as a trusted partner in education and assessment.