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
Relationships Really Do Matter
How you manage your partners is one of the first things an auditor looks for
Tuesday, September 07, 2010
How you manage your partners is one of the first things an auditor looks for
Tuesday, September 07, 2010
LDT: Legal Distinction Terminated
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
Bells, Whistles, and the Quest for Clinical Utility
Increasingly, FDA is becoming reluctant to clear tests that have a vague or general clinical utility.
Thursday, November 05, 2009
Increasingly, FDA is becoming reluctant to clear tests that have a vague or general clinical utility.
Thursday, November 05, 2009
Enlightened Empowerment
The concept of giving people the power to do their job is sound, but it is frequently not well implemented.
Thursday, July 09, 2009
The concept of giving people the power to do their job is sound, but it is frequently not well implemented.
Thursday, July 09, 2009
Designed for (Future) Success
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
Verification: It's Not Just a Phase...
There is more to verification, Horatio, than is dreamt of in your system evaluation!
Tuesday, May 26, 2009
There is more to verification, Horatio, than is dreamt of in your system evaluation!
Tuesday, May 26, 2009
Which V is Which?
hey're often called V&V, but what is the difference, what do they have to do with design control and how do they relate to process validation?
Monday, May 18, 2009
hey're often called V&V, but what is the difference, what do they have to do with design control and how do they relate to process validation?
Monday, May 18, 2009
A PMA Is Not the Kiss of Death
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
Turning Project Managers Into Project Leaders
A pack leader doesn't scream, get excited, or frustrated. They lead with what Cesar calls "calm, assertive energy."
Friday, April 03, 2009
A pack leader doesn't scream, get excited, or frustrated. They lead with what Cesar calls "calm, assertive energy."
Friday, April 03, 2009
Your Process is Your Product
Making good, safe, reliable, robust products that meet the customer and the companies needs is all about the process by which it happens.
Monday, February 23, 2009
Making good, safe, reliable, robust products that meet the customer and the companies needs is all about the process by which it happens.
Monday, February 23, 2009
Creating Value in Difficult Times
How do you build value while you're cutting budgets?
Wednesday, November 12, 2008
How do you build value while you're cutting budgets?
Wednesday, November 12, 2008