Commitment to Quality
At Beekley Medical, we are committed to providing our customers with safe, effective, high-quality medical products. Our commitment to quality begins with our associates. All Beekley associates play a part in the quality of our products as outlined in our Beekley Quality Policy.
Beekley Quality Policy
At Beekley Medical, we are committed to providing high-quality medical devices that meet the needs of our customers and comply with all applicable requirements.
We strive to ensure the safety, performance, and reliability of our products by:
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Maintaining the effectiveness of our Quality Management System in compliance with ISO 13485, FDA 21 CFR 820, and all other applicable regulations
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Establishing and reviewing quality objectives
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Empowering all associates to work together in support of quality
Quality Certifications
Each and every associate plays an integral part in the success of Beekley Medical’s quality management system. This focus has resulted in earning certification to the internationally recognized standard for medical device quality management systems, ISO 13485:2016. The certification shows that Beekley Medical has demonstrated the ability to provide medical devices that consistently meet customer and applicable regulatory requirements.
Regulatory Compliance
The safety and effectiveness of our medical device products are kept in compliance with FDA 21 CFR 820, EU Medical Device Regulation (EU MDR), EU In Vitro Diagnostic Medical Device Regulation (EU IVDR), Canadian Medical Device Regulations (CMDR), as well as all other applicable medical device regulations.
Beekley Medical distributes products to over 60 countries and complies with international medical device regulations, including Europe.