Training

Training, besides being a requirement, is an asset for individuals performing tasks that affect the quality of products and services supplied by companies.

Ensuring that staff members are properly trained is a fundamental part of a company’s operations.

At Carjes Soluciones, we have qualified trainers who offer our clients customized training courses tailored to each company’s needs. This training can be provided through courses covering the following subjects:

• Regulation MDR 2017/745 for medical devices.
• Regulation MDR 2017/746 for IVD products.
• Quality management systems ISO 13485, ISO 9001, and ISO 15189.
• Risk management according to EN ISO 14971.
• Clinical studies and clinical evaluation of medical devices.
• Biological evaluation according to EN ISO 10993.
  Design and validation of medical devices.
• Sterilization of medical devices.
• Software as a medical device.
• Usability of medical devices.
• Technical documentation of medical devices.
• MDSAP (Medical Device Single Audit Program)

Additionally, we collaborate in providing formal training for notified bodies and universities.