Content By Grant Ramaley

Grant Ramaley’s picture

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.

Grant Ramaley’s picture

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.

Grant Ramaley’s picture

By: Grant Ramaley

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

Grant Ramaley’s picture

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.

Grant Ramaley’s picture

By: Grant Ramaley

Some European Commission notified bodies have been forcing a position that a medical device must conform to the latest technical standards to meet the European legal requirement for “state of the art.” As a result, some manufacturers have been pressed into paying tens of thousands of dollars to retest their products or risk losing their CE Mark.