With experience since 2002 in medical device Quality Assurance, Mr. Goldstein is the Senior Director of Quality Assurance at MCRA. His primary focus is on quality system requirements for bringing new devices to market and on keeping experienced manufacturers in compliance with FDA and Notified Bodies. Mr. Goldstein provides MCRA clients with gap assessments, mock FDA inspections, Form 483 remediations, manufacturing transfers, Design History Files, Technical Documentation and MDD-to-MDR updates.
Prior to joining MCRA in August 2016, Mr. Goldstein worked in Quality Assurance for various medical device manufacturers. Mr. Goldstein updated, streamlined and maintained quality systems for compliance with ISO standards and with regulations for FDA, EU, Canada and Australia. He hosted FDA inspections and Notified Body audits, produced annual PMA reports to FDA and created EU-compliant Technical Documentation and FDA-compliant Device Master Records. He collaborated with hardware and software engineers, research scientists and manufacturing staff to create component specifications, and led numerous training sessions on regulations and standards. Mr. Goldstein planned and directed validations of hardware design, software design and manufacturing processes to build fully compliant Design History Files.