Simplified Regulatory Solutions for the Global Medical Device Industry
One World. One Regulatory Solution.
Let OneRA's expertise help you
navigate through any regulatory situation
The source for your regulatory and quality needs in the ever-changing global medical device industry.
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How can OneRA help you?
Regulatory
One world, many countries. OneRA will help you achieve global success through understanding clearly the needs of each region and delivering adaptable submissions.
Quality Systems
One size does not fit all. OneRA will help you implement the right solution that grows as you grow.
Design Control
Do what is necessary and sufficient. OneRA will help you refine one adaptive process to meet the requirements of the total product development lifecycle.
Risk Management
The safest medical device is the one not approved. OneRA with show you how to balance the risk/benefit scale.
Remediation
“Failure to correct the violations promptly may result in legal action…”. OneRA will help you no longer fear these words or other actions.
Coaching
Give a man a fish, feed him for a day. Teach a man to fish, feed him for a lifetime. OneRA will help you be a learning organization minimizing the need for outside support.
About OneRA
OneRA delivers rapid, positive responses from the FDA and global regulatory authorities whether it be related to a submission, audit and inspection observations, quality systems or the day-to-day activities of most medical device companies. Whatever your needs or concerns are, we can help. We have over +30 years of medical industry experiences in regulatory, quality, engineering, and manufacturing. We have worked with medical device startups and leading global providers of world-class devices and treatments.
Regulatory Affairs is an ever-learning adventure. We research regulations globally and understand the technology behind the devices we work with. We uphold trust-based internal relationships with Regulatory Affairs, gathering all information before communicating a submission strategy. This applies to every aspect of the medical device industry we support.