Training
Diagnosis
We help you to master the best practices to make you autonomous
How We Function
For each situation, we have the right solution for you.
Together, we transform your habits to comply with the standards
Advice
We get to know you and help target your needs
Optimisation
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.
Improvement
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.
Training
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 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.
Benefits:
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Ensure safety and effectiveness of your products and services
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Integrate ISO 14971:2019 into the risk management of your devices
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Speak the same language as all medical device manufacturers
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Improve product and service traceability
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.
Benefits:
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Access the American market
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Be ready for any routine or unannounced inspection
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Avoid unexpected surprises
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Apply and follow strict regulations
