Kevin Ladd Vice President, Quality Assurance

Mr. Ladd manages and directs the quality assurance for MCRA and its clients. Mr. Ladd creates, modifies and implements quality systems for device manufacturers & developers. He also ensures compliance with FDA QSR systems, ISO 13485, European Medical Device Directives and other international regulatory agencies.

Since 2000, Mr. Ladd has provided engineering, quality system and international regulatory consulting services to 17 companies, 9 of which were in the orthopedic field. Most recently, Mr. Ladd has worked with a spine non-fusion company to create the quality system and obtain ISO 13485 and Medical Device Directive (MDD) certification in less than six months of the founding of the company. In addition to CE marking spinal devices for distribution in the European Union, Mr. Ladd has obtained registration approvals in more than 15 additional countries.

From 1998 to 2003, Mr. Ladd was a subcontractor for TÜV America, a subsidiary of TÜV SÜD AG. He performed over 200 compliance audits of more than 100 different companies (>450 days of auditing), and was lead auditor in approximately 85% of all audits. In addition,he performed more than 200 days of documentation review including the review of orthopedic design dossiers, technical files and procedures. He was certified by TÜV America as an auditor / lead auditor to ISO 9001, ISO 13485, MDD and CMDR, and was the US “expert” for orthopedic devices including trauma, hip, knee, shoulder and spine. Further, he was certified as an “expert” for review of sterilization validation and control (gamma, ethylene oxide and steam).

Mr. Ladd has worked in the medical device industry for more than 20 years. Prior to becoming a consultant, Mr. Ladd assisted the formation of CardioRhythm, a cardiac arrhythmia management company that was acquired by Medtronic. At CardioRhythm, Mr. Ladd was the Director of Instrument Systems and managed Design Engineering and Manufacturing. Mr. Ladd has worked at several other medical device companies including Advanced Cardiovascular Systems and EndoTherapeutics, typically as a design engineer.

Mr. Ladd received his Bachelor in Science in Material Science & Engineering in 1982 at the Massachusetts Institute of Technology.