With 16 years' experience in medical device Quality Assurance, Mr. Dan Goldstein is a Manager 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, Design History Files, Technical Files, Summary Technical Documents, and Clinical Evaluation Reports.
Mr. Goldstein received his Bachelor of Arts from Maryland University College. He is certified by the American Society of Quality (ASQ) as a Certified Quality Auditor (CQA) and is trained by the British Standards Institution (BSI) as an ISO 13485:2016 Lead 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 MDD-compliant Technical Files and FDA-compliant Device Master Records. He collaborated with hardware and software engineers, research scientists, and manufacturing staff to create components 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 from the first phase to the last.
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.