Training 

Today's business world requires extraordinarily talented people capable of applying their knowledge in the workplaces.We are committed to contributing to the development of these people through their training.We also recognize that the ways of delivering such training have changed in recent years. That is why we are continuously researching and innovating to adapt to the new needs of our students.We offer public courses in various formats as well as custom-made courses for our clients.

Audit

Plan, execute and report internal quality audits to assess the quality system in accordance with ISO 13485 and international regulations.
Technique File

Validation

Plan and execute process, equipment and support system validations at a Medical Device manufacturing site.
Technique File
Technique File

Risk Management

Participants will learn to apply concepts and requirements of Risk Management process established in ISO 14971:2007 and ISO 13485:2016 in the product realization processes and other processes of the quality management system.
Technique File

Quality Tools

Effectively apply statistical tools of quality at work.
Technique File

Standards and Regulations

Understand the requirements of FDA´s Good Manufacturing Practices (GMP), known as Quality System Regulation applicable to Medical Devices.
Technique File
Technique File

CAPA and Investigations

Apply a systematic methodology and associated tools to conduct investigations and Root Cause Analysis in quality problems.
Technique File

Microbiology, Environmental Control and Sterilization

Distinguish the most important concepts and activities of microbiological an environmental control in the production of Medical Devices.
Technique File
Technique File