by Jack Slovick | Apr 2, 2016 | ISO
The 2016 revised standard of ISO 13485:2003 is coming; ISO 13485 – the internationally recognized quality management systems standard for the medical device industry – has been updated after thirteen years. The final version of this standard was published on March...
by Jack Slovick | Feb 19, 2016 | FDA
Today, the Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff.” Medical...
by Jack Slovick | Oct 8, 2015 | EU
The EU Council has released a draft of their position on the proposed MDR and IVDR. On 5 October 2015, the Ministers of the EU countries agreed on the General Approach of the position. The Council, Parliament, and Commission will negotiate the various proposals into...
by Jack Slovick | Aug 28, 2015 | ISO
The white paper aims to help you better understand the contents and potential implications of the proposed changes to quality management system requirements in ISO/FDIS 9001, issued in July 2015. Download the white paper from SGS...
by Jack Slovick | Aug 28, 2015 | FDA
Are you ready for September 24, 2015? In just over a month, several categories of Class I and II devices will reach their compliance due date for labeling requirements under the Unique Device Identification (“UDI”) regulations. For companies with implantable,...
