Quality
Our quality process ensures that your device will perform as required, works in a safe manner and meets your development schedule. Our process is rigorous but not burdensome and can be used stand-alone or in conjunction with a client’s system. If needed, we can also seamlessly utilize your system alone.
• Quality System follows strict quidelines which eases the process
of 510K and PMA submissions
• Fully compliant with EN 46001, enabling CE marking
• Meets FDA requirements established in 21 CFR 820.3 and
21 CFR 820.30
• Designed for Class III medical device development
• EN 13485 compliant
• ISO 9001 compliant
Risk Analysis Model>
Our quality process ensures that your device will perform as required, works in a safe manner and meets your development schedule. Our process is rigorous but not burdensome and can be used stand-alone or in conjunction with a client’s system. If needed, we can also seamlessly utilize your system alone.
• Quality System follows strict quidelines which eases the process
of 510K and PMA submissions
• Fully compliant with EN 46001, enabling CE marking
• Meets FDA requirements established in 21 CFR 820.3 and
21 CFR 820.30
• Designed for Class III medical device development
• EN 13485 compliant
• ISO 9001 compliant
Risk Analysis Model>