QUARA Innovations LLC

QUARA Innovations delivers scalable regulatory and quality systems solutions that address the entire life cycle of your medical device, healthcare or lifesciences business whether an entrepreneurial or enterprise sized organization.

How We Work:

We dive in deep to fully understand your business to build
quality systems from the ground up, prepare for FDA inspections, manage quality system and notified body audits, develop diligent surveillance practices and get the support you need. That’s why businesses of all sizes rely on QUARA for a range of risk mitigation and compliance services.

Who We Serve:

For Entrepreneurial Firms: Before you break into the market with a lifesaving medical device, you need a partner who can guide you toward compliance. QUARA understands the stringent FDA requirements and can prepare you for an FDA inspection, and provide assistance in meeting regulatory requirements and responding to requests.

• Understand the regulatory requirements
• Establish a suitable and effective quality system
• Manage your FDA inspections
• Engage a quality and regulatory officer on a contract basis
• Minimize risk so you can go to market
• Get training support, including Quality system Inspection
Technique (QSIT) readiness

For Enterprise Organizations: We provide a full range of FDA inspection and compliance services so you can prepare for and manage the results of an audit. We design tight processes and controls to keep your business compliant so it can stand up to ongoing surveillance.

• Refresher training
• Responding to inspectional observations
• Remediation planning
• Corrective and Preventive Actions
• Q&R support for corporate transactions, M&A, spin-offs
and re-organizations

What We Do:

– Tailored FDA Compliance
– Quality & Audit
– Medical Device Post-Market
– Regulatory & Quality Systems
– Training & Education
– FDA US Agent and Official Correspondent

Company’s Keywords:

management controls, fda us agent official correspondent, quality systems, inspectionaudit management, fda inspections, remediation, regulatory compliance, supplier quality