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Give yourself the tools to succeed. Benefit from the advice of our experts, integrate good quality practices and obtain your certifications to bring your innovations to market on time.

How We Function

For each situation, we have the right solution for you.

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We get to know you and help target your needs


Together, we transform your habits to comply with the standards


We help you to master the best practices to make you autonomous


We adapt your processes to improve your productivity on a daily basis

Our Tailor-made Services


Quality Implementation

Avoid unnecessary mistakes and save time. Hire experts on the get-go to support you in the creation of your quality management system.

We support you from the beginning of the project all the way to certification. Acting as guides, we train you to understand the standards and to assemble the best team for carrying out the project. We provide you with tools to structure your business and improve the efficiency and conformity of your processes. We can also help you in the writing of your documentation.

Internal Audits

Don’t lose your certification. Evaluate your quality management system and ensure its conformity to standards.

Our ISO 13485:2016 and ISO 9001:2015 certified lead auditors help you identify opportunities for improvement and non-conformities through a precise diagnosis of the state of your system. We provide practical recommendations to ensure that your certification is maintained.


Don’t make the same mistakes again. Update your best practices and reassess the conformity of your processes.

We update your processes to new quality requirements to ensure continued conformity of your system. We support you in your change management and the implementation of new working methods.


Be in control of your processes. Improve your knowledge and develop your everyday quality reflexes.

We offer interactive and personalized training courses tailored to your needs. Provide your teams with the means to successfully engage in your quality processes.

Quality Standards

ISO 9001:2015

Quality Management System Requirements

Applicable to any industries, implement this standard to ensure client satisfaction and continued improvement.



  • Identify your key processes
  • Ensure client satisfaction
  • Increase client confidence
  • Stand-out for your efficiency
More information

ISO 13485:2016

Quality Management System Requirements for Medical Devices

International standard defining requirements ensuring the safety and effectiveness of medical devices. Implement this standard to access European and Canadian markets. Soon also required for the American market.



  • Ensure safety and effectiveness of your products and services
  • Integrate ISO 14971:2019 into the risk management of your devices
  • Speak the same language as all medical device manufacturers
  • Improve product and service traceability
More information

21 CFR 820

Quality System Regulations for the United States of America

Regulations ensuring the safety and effectiveness of medical devices and defining good manufacturing practices (GMP) required for marketing a medical device in the United States of America.



  • Access the American market
  • Be ready for any routine or unannounced inspection
  • Avoid unexpected surprises
  • Apply and follow strict regulations
More information

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