Training and Coaching

MDProject can provide tailor-made training on-site at your company or at external locations. Training on-site can also include practical coaching and teaching of people while working on the subject in parallel (contact us to learn more about this effective approach). Training can be provided in the English and Dutch language. If required, the training can be concluded with an examination and/or certificate.

We offer a wide range of trainings and our expert trainers have many years of practical experience in their own particular areas of the Medical Device Industry. Training on the following topics can be provided:

– Introduction to the Medical Device Directive
– ISO 13485 – Quality Management Systems
– CE Marking according to the European Medical Device Directive(s)
– Device classification and conformity route assessment
– Content Technical File and STED filing
– Complaint, Recall, and Vigilance systems
– Risk management according to EN ISO 14971
– Project Management in Design and development processes
– Clinical (study) evaluation, Shelf life, Labeling, Packaging and Sterilization
– Post Market Clinical Follow-up (PMCF) and Post Market Surveillance (PMS)
– Biocompatibility and safety issues
– Clean room validations and monitoring
– Equipment qualifications and validation
– Internal & supplier auditing
– Requirements for US, Australia, and New Zealand

If the topic that you are looking for is not in the list, please contact us to discuss your particular requirements.