Content By Grant Ramaley

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By: 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 Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485 certificates, which had been granted under the purview of the Canadian Medical Devices Conformity Assessment System (CMDCAS), with any expiration dates beyond Dec. 31, 2018.

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By: 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 database for quality management system (QMS) certifications should be created.

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By: Grant Ramaley

Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.

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By: Grant Ramaley

Electrically powered medical equipment will soon be subject to the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.

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By: Grant Ramaley

Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately, they were ordered to stop issuing CE certificates.