Ready for QA/RA to evolve from an expense to a true asset for your business?

Our QARA consultants advise and implement quality and regulatory practices tailored to your medical device business.

QARA advice and implementation thatgrow your business

For any medical device business, QARA should be an integral part of the daily operations and strategy. We make that happen, so you can

Optimize internal overhead costs

Increase product quality and process efficiency

Reduce time to market clearance

A tailored route to quality and regulatory success  

1. First, we do an intake call to learn about your specific needs

2.  We start a discovery project (<1 week) with agreed-upon deliverables

3.  Through hands-on execution or coaching, we help implement the advice from the discovery

Solid experience in QMS and product registration of medical devices

Our team of engineers combine technical knowledge in the medical field with a strong expertise in Quality Assurance and Regulatory Affairs, ranging from class I devices over sterile devices to patient-specific (custom-made) surgical instruments, implants, and various stand-alone software applications

Specifically, our expertise covers

ISO 13485: Set up ISO13485-certified and FDA cGMP compliant QMS from scratch

Define and execute regulatory strategies for EU and US, incl. FDA interaction (QSub), 510(k), De Novo, CE certification

Support in the development process of medical devices to increase market clearance success

Here's how we've helped others

"Thanks to the professional regulatory team for boosting US access of Customize."

Khanh Tran Duy

CEO, 3D-side

Talk to one of our experts

OrthoGrow Advisory

OrthoGrow Advisory offers dedicated and specialized consultancy services in sales, quality and regulatory and general business aspects for medical device manufacturers. OrthoGrow analyzes, advises, plans, co-implements and manages orthopedic business growth through market expansion both strategically and tactically. 

OrthoGrow Advisory is part of the OrthoGrow Group.

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