As a (prospective) manufacturer of in-vitro diagnostic (IVD) medical devices, you aim to bring your product to market as quickly, effectively, and cost-efficiently as possible while ensuring compliance with the legal requirements of the countries where you plan to distribute your product. The training on in-vitro diagnostic medical devices provides you with insights into all relevant laws and regulations and offers practical guidance to meet these requirements.
The training on In-vitro Diagnostics (IVDs) for medical devices familiarizes you with the European In-Vitro Diagnostic Medical Device Regulation (IVDR). In-vitro diagnostics (IVDs) are diagnostic tests that examine samples taken from the human body, such as blood or urine, outside of the body. Examples of IVDs include blood glucose meters, pregnancy tests, and tests that indicate whether someone has a genetic disease.
Topics covered in this training include risk classification, assessment by Notified Bodies, quality management system and product requirements. It also delves into the relationship with and use of harmonized ISO standards, MEDDEVs (Medical Devices Documents) – working groups, and Global Harmonized Task Force documents (study groups). Additionally, you will learn about risk analysis, validation, clinical performance evidence, post-market surveillance, labeling, complaints, vigilance, and the recall process.
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination with your company-specific situation and the deployment of highly experienced lecturers who have earned their spurs in practice is essential here. Mikrocentrum is CEDEO-recognized and guarantees the best quality.
Are you interested in an incompany process? Our training manager Barend Blom will be happy to visit you without obligation.