To stay competitive in a quickly changing environment, with changing employees, regulations, standards and customer expectations, a company continuously need training.

MARACA International has established a series of training modules around the new European Medical Device Regulation, the European IVD Regulation, the US Medical Device regulations, the Quality System, ISO13485, ISO14971, design control, risk management, GDPR and technical documentation and conformity assessment. These training sessions are available as e-learning or as class-room training from 0.5 – 1 day, are given in English  and can be organized in your company or another place of your choice, anywhere in the world.

MARACA International training sessions are interactive and focus on practical implementation for your products. MARACA International trainers are experienced in the subject, know the issues and provide practical solutions for your company.

Training certificates are issued to the participants of class-room training.

List of class-room training courses

• New EU IVR Regulation 2017/746
• New EU MD Regulation 2017/745
• IVD Directive 98/79/EC
• Medical Device Directive 93/42/EEC
• GDPR
• Quality System
• ISO13485
• 21 CFR 820
• Design Control
• Risk Management
• Complaints, CAPAs, non-conformities
• Medical Device Reporting
• FDA submission: 510-k or PMA
• Medical vigilance and on-market surveillance