Quality and Regulatory Solutions
We ensure compliance while reducing your operational complexity
We are your strategic partner, put our expertise to work for you.
Overview
Combine Dukal’s industry-leading knowledge of quality and regulatory compliance requirements and our experienced global team to help you navigate the complexities of healthcare operations.
Benefits
Features
Dukal’s industry-leading knowledge of quality and regulatory compliance requirements continues to differentiate us as the complexity of product solutions increase. Our experienced global team ensures product compliance and specification requirements to protect the value of your brand.
Compliance
Dukal complies with ISO 13485, 21 CFR 820, and other relevant regulatory requirements.
Monitoring
Implementing and maintaining an effective quality and regulatory system is a crucial part of Dukal's beliefs.
Documentation
Through documentation and monitoring, Dukal improves efficiencies and customer satisfaction.
How Does Dukal Help You Navigate Supplier Qualification?
We work with suppliers at every step of the sourcing and manufacturing process to expand and accelerate supplier qualification to mitigate operational and financial risk.
> What is Dukal's quality policy?
We actively look for ways to maximize our potential and ensure all decisions are made with the highest levels of integrity.
Dukal, LLC will maintain a quality management system that commits to the highest standards of quality, safety, value, and customer satisfaction. This will be achieved with the commitment of management and the participation of all Dukal employees. Dukal's commitment includes complying with ISO 13485, 21 CFR 820, and other relevant regulatory requirements (download our ISO Certificate here). The Dukal quality management system will be continually reviewed for suitability and maintained for effectiveness.
Implementing and maintaining an effective quality/regulatory system is a crucial part of Dukal's beliefs. The quality and regulatory systems are the foundation for maintaining compliance, driving improvement, effectiveness and achieving stakeholder confidence in the products and in the company.
Through documentation and monitoring, Dukal consistently improves our processes to minimize error, resulting in improved efficiencies and customer satisfaction. Data driven results show that our quality management system is able to contribute to attaining business practices across all departments.
Dukal's leaders define the vision, mission, and what the “win” looks like for the future. This allows the quality and regulatory department to define a clear path, plan accordingly and support the mission through to fulfillment. Dukal's methods for facing changes is a proactive approach that is ingrained in the fabric of the organizations culture.
> How does Dukal comply with the California Transparency in Supply Chain Act?
Dukal is committed in our business practices to reflect our company’s values, including treating people with respect and dignity. To learn more about how our policies comply with the California Transparency in Supply Chain Act, click here.
> How does Dukal comply with the California Health & Safety Code §§ 119400–119402 and the Comprehensive Compliance Program (CCP)?
Dukal declares compliance with California Health & Safety Code §§ 119400–119402 and has adopted a Comprehensive Compliance Program (CCP) in accordance with the law. To view our CCP and annual declaration of compliance, click here.
Integrated Electronic Quality
Management System (eQMS)
Manual processes increase your odds of being out of compliance. Dukal’s eQMS provides powerful workflows and reporting to prevent and stay ahead of disruptions – before they impact business and patient health.
Risk management
We ensure there are no gaps in the quality and regulatory requirements that could result in thousands of dollars in fines or lost product.
Document and policy management
We maintain strict document management with version control, revision control, and archiving capabilities to ensure clear documentation and policy management. Create, review, distribute and archive all controlled documents in a centralized and controlled framework.
Training investments
We emphasize and foster a quality mindset across our entire organization with a dedication to continuous education and learning. With expertise in the areas of risk management, testing, technical writing, chemical characterization, audits, and licensing to provide the highest level of quality and regulatory standards.
Audit management
In-house ASQ certified quality auditors ensure customer requirements are met through successful internal and external audits.
Issue and action management
Timely execute action to correct and prevent issues that impact patient and business health. We handle acknowledgement of complaints, containment, investigation, escalation, replacements/credits to customers, and resolution.
Quality and Regulatory
Dukal InSure™
Through streamlined processes that provide bigger-picture data, we work collaboratively to ensure our supply chain is more efficient and more accurate. Customers can feel confident and secure with inventory assigned at the factory level, eliminating the industry practice of arbitrary allocation.
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