Case Study: Life Support System 510(k)

A medium-size manufacturer of a complex electromechanical, software containing, life-support system was short of trained staff, yet needed to prepare a 510(k) submission on a tight schedule.

An AlvaMed consultant worked with the client's regulatory and engineering teams to draft the submission.

The draft 510(k) submission was delivered to the client on time.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control