Intertek is a Total Quality Assurance Provider, a globally recognized testing, inspection, and certification organization that helps companies ensure their products meet international quality, safety, and performance standards. With a presence in over 100 countries, Intertek works across industries including healthcare and medical devices to verify that products are manufactured, tested, and managed according to strict regulatory and quality requirements.1
For companies like BTNX, partnering with Intertek provides independent, third-party validation that our processes and products meet globally accepted standards. This level of oversight builds confidence for healthcare professionals, distributors, and partners who rely on consistent, high quality diagnostic solutions.
ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for medical devices. It ensures that organizations involved in the design, production, installation, and servicing of medical devices consistently meet regulatory and customer requirements, while maintaining product safety and effectiveness.2
Achieving ISO 13485:2016 certification involves implementing and maintaining a comprehensive quality system that includes:
- Document Processes: Clear procedures for design, development, production, and service.
- Risk Management: Systematic identification and mitigation of risks to product quality and patient safety.
- Regulatory Compliance: Adherence to applicable national and international medical device regulations.
- Traceability: Complete documentation and tracking of materials, components, and finished products.
- Corrective and Preventive Actions (CAPA): Processes to detect issues, implement solutions, and prevent recurrence.
- Continuous Improvement: Ongoing monitoring and evaluation of quality systems to enhance product safety and efficiency.
The Medical Device Single Audit Program (MDSAP) is an internationally recognized audit program that allows medical device manufacturers to demonstrate compliance with the quality management system requirements of multiple regulatory authorities through a single audit.
BTNX’s participation in MDSAP reflects a higher level of regulatory oversight beyond ISO 13485 alone, as the program incorporates country-specific requirements from regulators such as Health Canada, the U.S. Food and Drug Administration (FDA), Australia’s TGA, Brazil’s ANVISA, and Japan’s PMDA.
For BTNX, MDSAP participation supports efficient global market access while reinforcing our commitment to regulatory compliance, patient safety, and consistent product quality.
ISO 13485:2016 aligns with BTNX’s Quality Policy – CURE:
- Committed to high quality, innovative diagnostic solutions
- Understanding and meeting customer expectations
- Regulatory compliance and product safety as priorities
- Enhancing our quality system through continuous improvement
By integrating CURE principles into our ISO-certified processes, BTNX ensures every product is not only safe and reliable but also meets the evolving needs of healthcare professionals worldwide.
For BTNX, ISO 13485:2016 certification ensures that our rapid diagnostic solutions are manufactured to the highest standards of safety and reliability. It provides:
- Confidence for healthcare professionals using our products.
- Consistency in product quality across global markets.
- A framework for continuous improvement, supporting innovation and long-term excellence.
By maintaining our certification, BTNX demonstrates its commitment to quality, safety, and customer satisfaction, reinforcing our reputation as a trusted provider of rapid diagnostic tests.
Reference:
- Intertek. (n.d.). About Us. Intertek. https://www.intertek.com/about/
- ISO 13485:2016. (n.d.). ISO. https://www.iso.org/standard/59752.html
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