Quality First

About our practices

We invest in continuous improvement and technology excellence of our delivery teams, which we call Quality First. It represents a series of systems, products and methodologies that cover every aspect of our client relationship, as well as the standards to which we hold ourselves.

Our quality standards apply to more than just regulatory and compliance requirements in the way we design and develop products. They apply more widely to our recruitment process, team composition, internal and external communication, processes and methodologies. We not only deliver excellence in every aspect of our client relationships, but also in the relationships with our employees.

We’ve delivered a number of products with strict quality, security and compliance requirements, for which we have obtained CE, FDA and CFDA certifications, along with HIPAA and GDPR compliance. In short, our products fulfill the highest security requirements.

HTEC’s Integrated Management System Policy

Since its founding, HTEC Group Inc., including its affiliated companies (hereinafter referred to as “HTEC”or “we”), has built a reputation based on the expertise and responsibility of our management, engineers, and employees. Through a combination of intensive internal communication, self-assessment, and regular client feedback, HTEC is committed to delivering high-quality services, continually striving to meet—and exceed—client expectations.

Our commitment to continuous improvement and client satisfaction is reflected in the following principles and practices:

• We are guided by integrity and ethical values in all interactions with stakeholders.
• We foster partnerships with clients built on mutual respect and trust, ensuring successful and long-term collaboration.
• We adhere to industry standards and comply with legal and regulatory requirements, including maintaining ISO 9001, ISO 13485, and ISO 27001 certifications.
• We ensure reliable risk management and implement necessary safety precautions in all projects.
• We maintain clear communication between management and teams, allowing for swift adaptation to both internal and external changes.
• We emphasize the continuous improvement and education of our employees, staying current with modern practices and technologies to achieve optimal results.
• We attract, develop, and retain competent individuals who align with our vision.
• We respond promptly to client needs, adhering to agreed-upon terms without compromising the quality of the final product.
• We continuously enhance our integrated management system and the services we provide.
• We actively seek feedback from stakeholders and adjust our practices accordingly.
• We develop reliable medical devices and software in full compliance with the ISO 13485 standard, MDR, HIPAA, and other applicable regulations and industry standards.
• We ensure the independence of personnel responsible for data security.
• We strictly safeguard client data in accordance with the ISO 27001 standard, applicable laws, and client agreements.
• We ensure that all company operations and data-handling practices comply with relevant regulations for information security and privacy, including the EU GDPR and the California Consumer Privacy Act, to protect individuals’ privacy and rights.

While each employee is responsible for maintaining quality standards, the Quality Manager monitors the system and, in collaboration with top management, implements and administers new quality practices and standards.Through these measures, HTEC is dedicated to delivering reliable services, meeting client expectations, and creating long-term value for all stakeholders.

Our certificates

Feel free to download our certificates, and see that our working mantra is more than just words.

ISO 27001:2022

ISO/IEC 27001 is an international standard that specifies the requirements for the implementation of an information security management system (ISMS).

As a holder of this certificate, HTEC has demonstrated the ability to preserve the confidentiality, integrity and availability of information, ensuring that the risks are adequately managed.

ISO 13485:2013

ISO 13485 is an international standard that specifies the requirements for a quality management system specific to the medical devices industry.

This standard guarantees that HTEC can handle strict medical devices regulations and policies, while staying committed to safety, efficiency and quality.

ISO 9001:2015

The ISO 9001 standard ensures that the management system quality requirements of an organization, and the products and services it provides, are met. It covers multiple markets and industries and prioritizes customer satisfaction.

HTEC consistently demonstrates that production quality and customer satisfaction are top priorities.