Training on compliance for Medical Devices and IVD

This service provides specialised training to equip teams with the knowledge and skills required to ensure compliance with international regulations for medical devices and in vitro diagnostic (IVD) products. The training covers regulatory frameworks such as FDA, MDR, IVDR. The service includes: 1. Needs Assessment: Identification of training gaps and definition of learning objectives. 2. Training Delivery: Delivery of tailored modules on regulatory compliance, QMS (ISO 13485, GMP), and inspection readiness. 3. Evaluation and Follow-up: Assessment of learning outcomes and provision of additional support if needed. Training programmes typically range from 1 to 3 months, depending on the depth and customisation required. The service is designed for professionals in the medical device and diagnostics sectors, including regulatory affairs, quality assurance, R&D, and production teams. The goal of the service is to enhance internal competencies in regulatory compliance, quality management, and inspection readiness, enabling organisations to meet global market requirements. Training is delivered by in-house or outsourced experts with proven experience in regulatory affairs and quality systems. Training is offered in-person, online, or in hybrid format, depending on the client’s preferences and logistical needs.