Regulations

Design Controls: Design Verification and Validation

This editorial is the fifth in a series of six articles focused upon the design controls process from a standpoint...

Sep 30 2010, John Gagliardi

Almost every inventor has asked, “Can I get an international patent?” The simple answer is, no. Let’s be clear, there is...

Having worked in medical device research and development for over 20 years, I have contributed to many regulatory submissions for...

Dear Reader, I attempted to read all 234,812 words of the Patient Protection and Affordable Care Act. (By comparison, Harry Potter...

Jun 30 2010, BONEZONE Editors

This is the fourth in a series of articles focused on the design controls process from a standpoint of business...

Jun 30 2010, John Gagliardi

Remember back to your youth when keeping secrets was an everyday occurrence? Sometimes it was between classmates or siblings, and...

This is the third in a series of articles focused on the design controls process from a standpoint of business...

Mar 31 2010, John Gagliardi

The world changed as we knew it on June 8, 1995, when the United States Patent and Trademark Office (“USPTO”)...