Leading With ISO Certification at BioTouch

At BioTouch, quality isn’t just a process—it’s part of our DNA. Across our international family of companies, we proudly maintain adherence to leading ISO® standards, including ISO® 13485:2016, ISO® 9001:2015, and ISO®/IEC 27001. These certifications reflect our unwavering commitment to excellence, continuous improvement, and globally recognized quality management practices. 

Certified Excellence: ISO 13485:2016, ISO 9001:2015 & ISO/IEC 27001 

ISO® 13485:2016 – Quality Management for Medical Devices 
ISO® 13485:2016 sets the benchmark for organizations involved in designing, producing, and servicing medical devices. Certification demonstrates that our processes consistently deliver safe, effective products and comply with global regulatory requirements—reinforcing our commitment to patient safety and operational excellence. 

ISO® 9001:2015 – Quality Management 
ISO® 9001:2015 applies to organizations across all industries, emphasizing customer satisfaction, operational efficiency, and continuous improvement. By aligning with this standard, we ensure our products and services are reliable, consistent, and designed to meet—or exceed—customer expectations. 

ISO®/IEC 27001 – Information Security Management Systems (ISMS) 
ISO®/IEC 27001 is the international standard for information security, providing guidance for establishing, maintaining, and improving an ISMS. Our certification ensures that sensitive information is protected across all operations, reflecting BioTouch’s dedication to security, compliance, and trustworthiness. 

Legacy Company Certifications 

Each of our legacy companies upholds the same high standards of quality, with certifications spanning multiple ISO standards: 

• ISO® 13485: Georgia, U.S. | Download Certification 
• ISO® 9001: Idaho, U.S. | Download Certification 
• ISO® 13485: Rhode Island, U.S. | Download Certification 
• ISO® 13485: Shannon, Ireland | Download Certification 
• ISO® 27001: BioTouch™ | Download Certificate 

Why ISO Certification Matters 

• Assurance of Quality 
  ISO 13485:2016 and ISO 9001:2015 certifications confirm that our processes and products meet rigorous quality standards, giving customers confidence in consistent, reliable outcomes. 
• Commitment to Compliance 
  ISO adherence ensures our operations align with global regulatory requirements, reducing risk and reinforcing our dedication to patient safety and legal compliance. 
• Enhanced Customer Satisfaction 
  Through certified processes and continuous feedback, we respond quickly to customer needs, delivering products and services that exceed expectations. 
• Streamlined Processes 
  ISO standards drive process efficiency, reduce waste, and ensure timely delivery, benefiting customers with reliable, high-quality service. 
• Global Recognition 
  Our ISO certifications are respected worldwide, providing assurance of our capability and credibility across all markets. 
• Risk Mitigation 
  Risk-based approaches required by ISO standards allow us to proactively identify and address potential risks, safeguarding end-users and clients alike.