With experience since 2002 in medical device Quality Assurance, Mr. Dan 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.
Mr. Goldstein received his Bachelor of Arts from University of Maryland University College. He is certified by the American Society of Quality (ASQ) as a Certified Quality Auditor (CQA), by BSI as an ISO 13485:2016 Lead Auditor, and by Exemplar Global (RABQSA) as an MDSAP and an EU MDR Auditor.
Prior to joining MCRA in August 2016, Mr. Goldstein worked in Quality Assurance for various medical device manufacturers, with specialties including autologous blood products for wound healing and computer-aided-detection software for lung diseases. 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.
Mr. Goldstein's work at MCRA focuses primarily on quality system requirements for bringing new devices to market and on keeping experienced manufacturers in compliance with FDA and Notified Bodies.