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Stradis Healthcare announced today that the company has received ISO 13485:2016 certification from the British Standard Institution (BSI). This certification represents the company’s quality management system maintains standards that meet or exceed requirements specific to the medical device industry, including contract services for packaging, manufacturing, fulfillment, design and testing.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO quality management standard embodies the requirements for a comprehensive management system for the design and manufacture of medical devices.
“Achieving 13485 certification demonstrates Stradis’ ongoing commitment to raising the bar on an already robust quality system as well as our commitment to patients and customers regarding our quality. Additionally, we felt that receiving certification coupled with a top down pledge to our employees reinforced our commitment and expectations around quality,” said Joseph Trznadel, Chief Operating Officer for Stradis Healthcare.
These certifications are a testament to the high level of performance and quality control expected at Stradis. With an expanding portfolio of customers, health indications and reach, this level of attention to detail is important to ensuring that the quality, safety and efficacy meet and exceed requirements.
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