Description: Aligning local practices with international standards for medical device quality.
Content:
– Analyzing ISO 13485 requirements and implementing them within healthcare organizations.
– Documenting design, maintenance, and calibration processes.
– Conducting compliance audits and driving continuous improvement.
Learning Outcomes:
– Ability to implement a quality management system in accordance with global best practices.
– Ensuring medical device reliability and patient safety.
Objectives: Developing quality and management teams within healthcare institutions.
Preparation for obtaining accredited certification.
Target Audience: Biomedical engineers, quality engineers, heads of biomedical engineering departments, and hospital accreditation officers.