Go to home page
Contact Us
View Locations
  1. All Solutions
  2. Quality & Compliance
Quality
Quality & Compliance

Leading With Quality

At BioTouch, we pride ourselves on our commitment to quality and excellence in everything we do. We are certified in ISO 13485:2016 and ISO 9001:2015 standards across our international family of companies. These certifications underscore our dedication to maintaining the highest standards of quality management systems and continuous improvement.

Quality & Compliance

Certified Excellence: ISO 13485:2016 & ISO 9001:2015

Certified Excellence

ISO 13485:2016 - Quality Management for Medical Devices

ISO 13485:2016 is an internationally recognized standard specifically designed for organizations involved in the design, development, production, and servicing of medical devices. This certification ensures that our processes meet regulatory requirements and consistently deliver safe and effective medical products and services. Compliance with ISO 13485:2016 demonstrates our commitment to patient safety and regulatory compliance throughout our operations.

ISO 9001:2015 - Quality Management

ISO 9001:2015 is a globally recognized standard for quality management systems applicable to all industries. This certification emphasizes our focus on meeting customer requirements, enhancing customer satisfaction, and continually improving our processes and operations. By adhering ISO 9001:2015 standards, we ensure efficiency, consistency, and reliability in our products and services, ultimately driving customer satisfaction and business success.

Legacy Company Certifications

As part of the BioTouch family, each of our legacy companies maintains its commitment to quality and holds certifications in ISO standards. These certifications across our legacy companies showcase our dedication to quality management, regulatory compliance, and customer satisfaction throughout our diverse range of services and products.

Benefits of Choosing a Certified Company

Assurance of Quality

ISO 13485:2016 and ISO 9001 certifications guarantee that our processes and products meet stringent quality standards. Customers can trust that they are receiving reliable and consistent products and services.

Commitment to Compliance

Compliance with ISO standards ensures that our operations align with regulatory requirements in the medical device industry. This commitment to compliance minimizes risks associated with non-compliance and demonstrates our dedication to patient safety.

Enhanced Customer Satisfaction

By adhering to ISO standards, we prioritize customer satisfaction and continually seek feedback for improvement. Our certified quality management system enables us to respond promptly to customer needs and deliver products and services that meet or exceed expectations.

Streamlined Processes

ISO certifications require us to establish and maintain efficient processes, leading to improved productivity and reduced waste. Customers benefit from streamlined processes that result in timely delivery of high-quality products and services.

Global Recognition

ISO certifications are globally recognized and respected, providing customers with confidence in our company's capabilities and reliability, regardless of geographical location.

Risk Mitigation

Through the implementation of risk-based approaches outlined in ISO standards , we proactively identify and mitigate potential risks associated with our products and services, ensuring the safety and well-being of end-users.

Continuous Improvement

ISO standards emphasize the importance of continuous improvement, driving us to regularly review and enhance our processes, products, and services. Customers can expect ongoing innovation and excellence as we strive for continual improvement.

Competitive Advantage

Choosing a certified company within the BioTouch family offers customers a competitive advantage in the marketplace. Our commitment to quality and compliance differentiates us from competitors and reinforces our position as a trusted partner.