QUALITY MANAGEMENT SYSTEMS

IF YOU MANUFACTURE MEDICAL DEVICES, YOU NEED A QUALITY MANAGEMENT SYSTEM.

WE WILL BUILD IT FOR YOU.

QUALITY MANAGEMENT SYSTEM

We have built dozens of ISO13485, ISO9001, ISO14001 and QSR(US) -compliant quality management systems for companies manufacturing various types of medical devices.

According to the MDR, a quality management system is mandatory for all medical device manufacturers. A well-built quality management system helps your company operate in a systematic manner and increases efficiency.

SPECIFIC DEMANDS

We collaborate with pharmaceutical companies and clinical investigation centers. By regularly auditing our collaboration partners, we have become proficient in the requirements for the GMP, GCP and GLP.

When building a quality management system, the key aspect is that the system is easy to use, regardless of the size of the company.

Our team takes care of building the quality management system until the certification point as well as the continuous maintenance of the system.

WE ARE FAMILIAR WITH THE MOST IMPORTANT QUALITY MANAGEMENT SYSTEM STANDARDS

ISO 13485

ISO 9001

ISO 14001

QSR (us)

GMP

GCP

GLP