How Can We Help You?
Your business lives in a complex regulatory environment with quality systems demands and compliance requirements that can put even smart, fast-thinking enterprises on hold. We get it. At QUARA Innovations, we understand that bringing your lifesaving technologies to market is your top priority—but accomplishing this also means passing demanding inspections, instituting detailed quality systems and processes, and meeting a litany of regulations. What are you going to do about that?
Mitigate risk and lift the burden of compliance.
Our goal at QUARA Innovations is simple. We want to smooth out the road of regulatory and quality requirements, so you can usher your medical devices to market. We partner with you, and work to understand every aspect of your business. As a team, we can anticipate regulatory and systems challenges, and design solutions that will keep you ahead of the compliance curve.
Access multifaceted expertise.
We’ve been on your side, facing FDA compliance and inspections, and working to develop process, design and documentation controls. With QUARA, you can leverage our extensive compliance capabilities. We act as an extension of your team, so you can tap our engineering expertise and deep quality, regulatory compliance experience.
Not sure where to begin?
Whether you’re an entrepreneurial firm or an enterprise-level company, QUARA provides a full range of regulatory and quality systems consulting and services to get you ready for market, and secure your sustainability in this competitive, highly-regulated marketplace.
Entrepreneur: 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 submissions, registrations and device licenses required. And, if you’re facing an FDA inspection or audit, you want to know what to expect—and how to respond to corrective action.
- Understand the regulatory requirements
- Establishing an adequate, suitable and effective quality system
- Managing your first FDA inspection
Enterprise: QUARA can come in at the ground level, providing a full range of FDA inspection and compliance services so you can prepare for and manage the results of an audit. Next, we can continue with designing 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
Looking for an experienced advocate?
Corporations across the world trust QUARA as a sophisticated advocate, and experienced, business-focused quality systems and regulatory affairs consultant. We help companies in the medical device, healthcare and life sciences spaces manage compliance issues and protect their ability to introduce lifesaving innovations to the market.