Medical Labeling Equipment
Develop a Strategy to Ensure Compliant Labeling Inspection
Sep 08, 2016
With half of all medical device recalls in recent years caused by packaging and/or labeling errors, it’s time for manufacturers to rethink their approach to...
Label Life Cycle Management Systems Enable Expansion for Medical Device Companies
Sep 10, 2014
Proactive medical device companies are taking a more strategic approach to the management of data by implementing fully integrated, end-to-end label life cycle...
Five Benefits of Equipment Financing for Start-Ups and Small Businesses
May 03, 2013
Small companies and start-ups can have trouble securing credit, but equipment financing can help them acquire the capital assets they need to grow.  Small...
Medical Device Labeling is Seriously Lagging
Mar 13, 2013
In Mary Weick-Brady’s estimation, the medical device labeling system is lagging behind CDER by at least 10 years. And, she says, device labels need a...
FDA Issues 3 Medical Device Guidances, Plus an Update on Labeling
Feb 19, 2013
FDA has issued three guidances relating to medical device electronic submissions, PMA acceptance and filing review, and 510(k) Refuse to Accept policy.  ...
Medical Device Labeling: CDRH Plans Drug-like Labels for Devices
Jan 30, 2013
CDRH plans to unveil an outline for standardized medical device product labeling at an April 29 public workshop exploring drug-like labeling formats for...
Labeling Mistakes and How to Avoid Them
Jan 08, 2013
By following best practices for labeling companies can also take greater advantage of the flexibility offered by electronic labeling.  Image...
IEC to Issue Amendment 1 to 60601-1, 3rd Edition Medical Electrical Equipment Standard
Jul 11, 2012
UPDATE: On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1).  It is on the IEC.ch...
Essential Performance of Medical Electrical Equipment
Aug 01, 2007
  RISK MANAGEMENT         In 2000, the International Organization for Standardization (ISO) published a document that describes...
IEC 60601-1: Medical Device Marking and Labeling
May 01, 2004
A device's labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed “a critical...