Regulatory

Documentation… the Basis of our “Packaging?!”

Once again I welcome back one of my favorite members of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems and Regulatory Operations Consultant. He loved writing last month’s issue so much that he came back begging to do it again! (right Jake?!?!?!)

Take it away!

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Which Came First, the Regulatory Chicken or the Egg?

Please…without further ado, let me introduce to you a member of the McCormick LifeScience Consultants Team, Diane C. Tiernan, M.S., RAC, a Device Regulatory professional possessing >25 years industry experience. Diane has worked in large and small device companies, and is currently a private medical device consultant.

DRUMROLL PLEASE……..

Take it Away Diane!

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Q-Submissions – Hot Off the FDA Press

I’d like to welcome back part of the McCormick LifeScience Team, Diane C. Tiernan, M.S., RAC, a Device Regulatory professional possessing >25 years industry experience. Diane has worked in large and small device companies, and is currently a private medical device consultant.

Read More

Documentation… the Basis of our “Packaging?!”

Once again I welcome back one of my favorite members of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems and Regulatory Operations Consultant. He loved writing last month’s issue so much that he came back begging to do it again! (right Jake?!?!?!)

Take it away!

Read More

Which Came First, the Regulatory Chicken or the Egg?

Please…without further ado, let me introduce to you a member of the McCormick LifeScience Consultants Team, Diane C. Tiernan, M.S., RAC, a Device Regulatory professional possessing >25 years industry experience. Diane has worked in large and small device companies, and is currently a private medical device consultant.

DRUMROLL PLEASE……..

Take it Away Diane!

Read More