The Essentials of Essential Requirements
The challenging part is trying to figure out which strategy of meeting the essential requirements works best for the manufacturer.
Wednesday, December 08, 2010
The challenging part is trying to figure out which strategy of meeting the essential requirements works best for the manufacturer.
Wednesday, December 08, 2010
Life on the A List
Requirements for List A products are similar to those for a PMA
Tuesday, November 09, 2010
Requirements for List A products are similar to those for a PMA
Tuesday, November 09, 2010
Assessing Conformity
The route is determined by intended use and risks to personal and public health
Tuesday, November 02, 2010
The route is determined by intended use and risks to personal and public health
Tuesday, November 02, 2010
Mind Your PQ's (and IQ's and OQ's)
These terms aren't defined in regulation, so what exactly do they mean?
Tuesday, October 05, 2010
These terms aren't defined in regulation, so what exactly do they mean?
Tuesday, October 05, 2010
Hearing Global Harmonization
Getting a handle on national and regional requirements can be time-consuming
Tuesday, September 28, 2010
Getting a handle on national and regional requirements can be time-consuming
Tuesday, September 28, 2010
CE Mark is Good, FDA Clearance is Great
Perhaps it is because of our regulation of the medical marketplace that it is such a valuable space to do business.
Monday, June 08, 2009
Perhaps it is because of our regulation of the medical marketplace that it is such a valuable space to do business.
Monday, June 08, 2009
Implications of the New RoHS Directives
It's never too early to learn about the purpose of the RoHS Directive.
Monday, January 26, 2009
It's never too early to learn about the purpose of the RoHS Directive.
Monday, January 26, 2009