We think like them. We understand you.
QUARA Innovations is your source for quality systems and regulatory affairs services. We are problem solvers. That means we dive in deep to fully understand your business to help you ensure compliance, prepare for FDA inspections, manage quality system and notified body audits, develop diligent surveillance practices and get the support you need.
A grassroots approach.
We know you’re passionate about your work, and that’s why we focus diligently on ensuring that your processes are inspection-ready and that there are no obstacles to your success. There’s no cookie-cutter system for medical device, life sciences and health care innovation companies like yours. At QUARA, we work one-on-one with you to tailor systems and procedures to help you meet your goals and manage regulatory affairs.
A trusted partner.
Our clients in the medical device and life sciences industries trust us to prepare them for FDA inspections, and so much more. We become an advocate, an extension of their teams if necessary, and a strategic partner who can assist with all levels of due diligence.
As a full-service regulatory consultant, QUARA Innovations offers comprehensive services in the quality and regulatory affairs space, including:
- Quality Systems FDA / ISO 13485 / MDD / CMDR
- FDA inspection readiness
- Quality systems
- Internal audits
- Notified body audits
- Post-market surveillance
- Supplier controls and audits
- FDA inspection process
- FDA-483 responses
- Warning letter responses and corrective actions
- Environmental and sustainability services
- Due diligence
Meet Eduard Toerek
At QUARA, we like to say that we “think like them,” and we understand you. That’s because of our extensive experience with regulatory agencies and industry in a range of leadership roles in quality and regulatory affairs. This positions us to help clients in the medical device and life sciences industries mitigate risk, achieve compliance, and stay up-to-date with regulations—while continuing to run profitable businesses.
QUARA Founder and President Eduard Toerek is an acknowledged executive leader with extensive global experience in regulatory compliance, quality systems, total quality management, and industry and government relations. Toerek’s expertise is in providing trusted counsel and advice to innovators in the medical device and life science industries, informed by years of experience with global regulators.
Toerek is a member of the American Society for Quality and Regulatory Affairs Professional Society, and he speaks fluent German. His active leadership roles in professional industry groups and government relations include NEMA/MITA, COCIR and the United States Access Board. He has held global leadership responsibilities for sites and employees across multiple regions, including Europe, the Middle East and Asia.