ISO 14971: Master Risk Management for Medical Device

ISO 14971 is an internationally accepted requirement that presents a Risk Management Process for Medical Devices. The standard focuses on the hazard identification feature of the medical device at every stage of its manufacturing and life cycle. It includes design, manufacture, and post-marketing surveillance. Through implementing ISO 14971 framework, producers can estimate, examine, and control the risks. Thus, they protect people's and users' safety. This certification only certifies the products and not the organization itself. ISO 14971 Certified professionals demonstrate competence in applying this standard through certifications offered by recognized bodies. They further act as drivers for the procurement and maintenance of a reliable risk management system in a medical device company.

From theory to practice: ISO 14971 Training for Risk Management

ISO 14971 Risk Management Training in Kigali, equips candidates with the needed skills to lead risk management of different medical devices used. The training course, workshops, and practical sessions, followed by case studies, will give candidates a deep understanding of the ISO 14971 standards' requirements. Participants will be trained with skills that include, but are not limited to, FMEA and FTA for risk identification, risk analysis and evaluation, and the selection of control methods to minimize the identified risk. It further ensures clear and transparent communication throughout the medical device’s lifecycle processes. Participants will be made ready to detect existing or presented hazards, thus creating a safety culture among patients and compliance with regulatory requirements.

Demonstrate expertiseby acing ISO 14971 Exam

To verify their level of competence with the learned information, participants would have to sit in and write a demanding ISO 14971 Risk Management Exam in Kigali at the end of the training program. This will be a multiple-choice exam that will assess the understanding of various topics presented in this program in detail. The exam will contain 30 questions with a time limit of 60 minutes. These topics will explain IS0 14971 framework, which includes various hazard identification techniques, risk analysis and methodologies, risk control strategies, and risk file management documentation. A minimum passing score of 70% shows a strong basis for earning ISO 14971 Certification.