Onebridge has over a decade of experience greatly easing the FDA & CE approval process, while also mitigating the risks of quality and compliance issues. We offer a structured and proven methodology for assessing the health of your quality systems and ensuring your compliance with medical device standards.
The international standard for Risk Management is becoming increasingly important on a global scale as many Regulatory Bodies are considering alignment to Medical Device ISO Standards.
We provide the guidance and insight you need to be a step ahead in planning for your Quality initiatives.
Regulatory Bodies require integrated Risk Management systems throughout the Medical Device product lifecycle.
Let us support your solutions through our experience of implementing industry best practices to comply with applicable standards.
Manage the Quality of your products through Post-Market Surveillance activities including Complaint Handling and Investigation.
We can support your improvements from issues identified by the end users and provide the throughput necessary to keep you current with your Complaint backlog.
Medical device and components manufacturers are under more FDA scrutiny than ever before, and it’s getting harder to understand which controls the FDA will consider adequate. Your quality system may be compliant today but relying on practices that could endanger your compliance in the future.
In 2017, the estimated cost of a single 483 remediation was $250,000.
In the last decade, the Quality Systems elements with the most FDA observations have consistently been P&PC, CAPA and Design Controls. In 2017, P&PC and CAPA subsystems alone accounted for 34% and 33%, respectively, of the total 483 observations issued by the FDA, followed by Design Controls with 13%.
Download our eBook on the FDA Enforcement Process to better understand what you should prepare for, and how we help companies manage the remediation process.
At Onebridge, our flexible risk-based approach to Quality and Regulatory implementation and remediation takes the guesswork out of compliance while keeping spend under control.
Instead of hoping the current state of your quality system is satisfactory and risking non-compliance during your next inspection, it’s crucial to take a proactive approach with early detection. We can help you visualize your compliance health information with easy-to-read dashboards, making it simple to: