about citoQualis

citoQualis- your trusted partner in quality and regulatory compliance. We specialize in tailored solutions for quality systems and regulatory affairs, supporting you throughout every stage of the product lifecycle.

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Our Mission

Our mission is to advance healthcare and improve lives by facilitating, accelerating and supporting the journey for medical device manufacturers to reach the market.

We provide comprehensive solutions aimed at creating and optimizing your documentation, allowing you to dedicate your energy to development. Our primary emphasis is on crafting intuitive and customer-centric solutions that not only serve their purpose effectively but also offer a pragmatic approach to achieving market access.

Teamwork

Teamwork is the foundation of collaboration and synergy within our organization. It means leveraging the diverse strengths, skills, and perspectives of each team member to achieve shared goals. By fostering an environment of mutual respect, open communication, and collective effort, we harness the power of teamwork to overcome challenges, drive innovation, and deliver exceptional results.

Customer Experience

Customer experience is at the heart of everything we do. It involves understanding our customers' needs, expectations, and challenges and going above and beyond to exceed them. By prioritizing responsiveness, empathy, and personalized service, we strive to create positive interactions at every touchpoint, building lasting relationships and earning trust and loyalty.

Trust/Accountability

Trust and accountability are the cornerstones of integrity and reliability in our organization. We believe in being transparent, honest, and ethical in all our dealings, both internally and externally. By taking ownership of our actions, honoring commitments, and holding ourselves and others accountable, we cultivate trust and confidence in our relationships and outcomes.

Continuous Improvement

Continuous improvement is ingrained in our culture as a driving force for growth and excellence. It means embracing change, seeking feedback, and constantly striving for better ways of doing things. By fostering a culture of learning, adaptability, and innovation, we empower our team to identify opportunities for improvement, experiment with new ideas, and evolve to meet evolving challenges and opportunities.

Engagement and Sustainability

Passion and engagement drive our dedication and enthusiasm for our work and our mission. It means bringing our whole selves to the table, energized and inspired to make a difference. By nurturing a culture of passion, enthusiasm, and empowerment, we create an environment where individuals are motivated to excel, collaborate, and contribute their best to achieve our shared vision.

Sustainability is our commitment to good health and well-being of people and our environment. It involves putting the good health and well-being of our team in focus, as well as responsible stewardship of resources and environmental conservation such as minimizing our ecological footprint, promoting eco-friendly practices, and supporting initiatives that contribute to the well-being of our planet and communities. By integrating sustainability into our mindset, we aim to create long-term value while safeguarding the planet for future generations.

At citoQualis, we aspire to make an impact on our world for future generations. We focus our work related to the United Nations Sustainable Development Goals, SDG, where we think we can achieve the greatest impact.

Quality

Quality is the hallmark of our commitment to excellence and customer satisfaction. It means delivering services that meet or exceed the highest standards of safety, efficacy, and reliability. By upholding rigorous quality standards, adhering to regulatory requirements, and continuously monitoring and improving our processes, we ensure that our products and services consistently meet the needs and expectations of our customers and stakeholders.

These core values serve as guiding principles that shape our culture, drive our behavior, and inspire us to achieve our mission and vision with integrity, purpose, and resilience.

Why citoQualis?

Expertise

With years of experience in the medical device industry, our team brings significant expertise and insight to every project. Our team of regulatory professionals boasts extensive experience and in-depth knowledge of global regulatory requirements, enabling us to provide strategic guidance and tactical support tailored to your specific needs.

Tailored Solutions

We recognize that one size does not fit all. Our solutions are customized to address the unique needs and challenges of your organization.

Comprehensive Support

From regulatory strategy development to post-market compliance, we offer end-to-end support to ensure your products meet regulatory requirements at every stage of the product lifecycle. From initial implementation to ongoing maintenance, we provide end-to-end support to keep your QMS running smoothly.

Efficiency and Timeliness

We understand the importance of speed to market. Our streamlined processes and proactive approach help expedite regulatory approvals, minimizing delays and maximizing market opportunities

Commitment to Excellence

We are committed to helping you navigate the regulatory landscape with confidence, integrity, and excellence, empowering you to bring safe and effective medical devices to market.We are committed to helping you achieve and maintain the highest standards of quality, safety, and compliance.

Meet The Team

Dan Negrea
Dan Negrea
Co-Founder and Managing Director
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Wolfgang Werner
Wolfgang Werner
Co-Founder and Head of Quality and Regulatory
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Catharina Poulet
Catharina Poulet
Managing Director
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Alexandra Maria Grigore
Alexandra Maria Grigore
Quality and Regulatory Consultant
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Ana Margarida Silva
Ana Margarida Silva
Quality and Regulatory Consultant
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Diana Nedelcu
Diana Nedelcu
Quality and Regulatory Consultant
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