Content by Grant Ramaley

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Grant Ramaley
As the 2020 pandemic threatened world health, a large number of unscrupulous companies began generating fake International Organization for Standardization (ISO) quality management system (QMS)...
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Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical...
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Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in...
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Grant Ramaley
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1...
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Grant Ramaley
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards...
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Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the...
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Grant Ramaley
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality...
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Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the...
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Grant Ramaley
On Dec. 23, 2015, a vote was taken among 78 nations with accreditation bodies that are part of the International Accreditation Forum (IAF). From the vote it was determined that a new international...
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Grant Ramaley
The European Cooperation for Accreditation (EA), an association of national accreditation bodies in Europe, has implemented the accreditation requirements of the International Accreditation Forum (...