Regulatory Documentation

Richardson Healthcare is dedicated to providing products and services of the highest quality, performance, and reliability.

ISO 13485:2016

In 2018, Richardson Electronics was awarded ISO 13485:2016 certification. This certification validates the consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. To be certified, Richardson Healthcare demonstrated the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

With this certification, customers can be confident that Richardson is dedicated to maintaining the highest level of quality, efficiency, and responsiveness.

ISO 13485 Press Release

MDSAP Certification

In 2021, Richardson Electronics was awarded MDSAP Certification.

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. To be certified, Richardson Electronics demonstrated the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

MDSAP 743094 Certificate

Canada Device License

Richardson received the Canada Device License for the ALTA750 (RELL43001035) on May 18, 2022. License number: 107770

ALTA750 Canada Medical Device License

Richardson received the Canada Device License for the ALTA750G on January 25, 2023. License number: 108809

ALTA750G Canada Medical Device License

CE 697580 Certificate

Richardson Electronics received the EC Certificate – Full Quality Assurance System, No. CE 697580

CE 697580 Certificate

FDA Registration

Richardson Electronics’ FDA registration number is 1120044 and can be verified by visiting the fda.gov website.

Richardson Electronics Corporate Quality Policy

Our company is committed to continuously improving the quality of our Engineered Solutions in a socially responsible manner while exceeding the expectations and needs of our customers, our employees and our technology partners.

Our principles include:

• Customer Satisfaction as Top Priority: We are dedicated to understanding and fulfilling the needs and expectations of our customers. We strive to offer products/services that exceed their requirements and ensure their satisfaction.
• Continuous Improvement: We pursue a culture of continuous improvement in all aspects of our business. Through regular review and assessment of our processes, we aim for efficiency gains, error prevention, and innovation while minimizing the impact of our operations on the environment.
• Adherence to Quality Standards: We are committed to maintaining the effectiveness of our Quality Management System and strict compliance with the requirements ISO 9001 and/or ISO 13485, as well as all relevant legal and national regulatory requirements. Our processes and products/services are developed, manufactured, and delivered according to the highest quality standards.
• Employee Engagement: Our employees are our most valuable asset. We foster an environment that promotes diversity, equity, teamwork, competence development, and dedication to quality and customer service. We ensure our employees receive the necessary resources and training to fulfill their duties effectively.
• Partnerships and Supplier Relationships: We aim for long-term partnerships with customers, suppliers and service providers who share our quality standards. Through close collaboration and communication, we strive for common goals and continuous improvement throughout the supply chain.

This quality policy serves as a framework for establishing and reviewing our quality objectives and processes. We are committed to continuously improving it and ensuring it is understood, implemented, and maintained at all levels and functions of our company.

Effective 6/14/2024