Lori A. Carr, Inc.

medical devices

About

Lori Carr, RAC (US), CQA (ASQ), President and CEO of Lori A. Carr, Inc., is a Principle Consultant in the Medical Device regulated industry. Lori has more than 19 years experience in the medical device industry and was a Medical Device Specialist FDA Investigator in both the Cincinnati and Denver District Offices of FDA. She conducted international and domestic inspections of medical device facilities and trained FDA investigators in conducting medical device inspections. As an FDA regulatory compliance consultant, Lori has performed numerous quality assurance audits for medical device companies. She has created and implemented quality systems and provided guidance on quality, regulatory, and compliance issues throughout the world. Her clients include companies that have received FDA Warning Letters, are under FDA injunction or have had product seized by FDA. In her capacity as a Medical Device Specialist, she conducted numerous domestic and international inspections to ensure compliance with applicable FDA regulations including routine GMP, Pre-market (PMA), 510(k), and directed inspections from the Center of Devices and Radiological Health (CDRH) while working in both the FDA Denver and Cincinnati District Offices. In 2010, Lori obtained the U.S. Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Certified Quality Auditor (CQA) certification from the American Society for Quality (ASQ).

Technologies

Cloudflare DNS CloudFlare Hosting WordPress.org Mobile Friendly Gravity Forms reCAPTCHA Google Tag Manager IoT AI Android Node.js

Keywords

document controls quality system developmentcontinuous improvement quality system training medical device reportable adverse events & product recalls fda inspections & warning letters fda quality system reg compliance audits amp gap analyses fda quality system reg compliance audits gap analyses medical equipment manufacturing medical device risk management consulting iso 13485:2016 services fda audit preparation medical device quality assurance medical device regulations capa procedures government fda inspection support 21 cfr 820 medical device reporting fda warning letter response regulatory consulting b2b quality management systems quality system audits fda inspection training medical devices gmp review fda 483 response medical device validation

Location

25602 E Indore Dr, Aurora, Colorado, United States, 80016-2852

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