About Lori
Lori Carr, RAC (US), CQA (ASQ), RABQSA
President and CEO of Lori A. Carr, Inc., is a Principal Consultant in the Medical Device regulated industry.
Lori has more than 30 years experience in the medical device industry. She 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 (including Bioresearch) 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 and clinical sponsors. She has created and implemented Quality Management 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, or are seeking FDA approval/clearance for marketing their products in the United States.
Medical Device Specialist
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.
Lori earned a Bachelor’s Degree in Chemistry from Xavier University and was a 2005 graduate of the federal government’s Office of Personnel Management Leadership Development Class.
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). In 2014, Lori obtained the ISO 13485:2003 Principal Auditor Certification from Exemplar Global (RABQSA), with an update to ISO13485:2016.
In 2018, Lori added the MDSAP (Medical Device Single Audit Program) and EUMDR Certifications to her repertoire of auditing competencies.
FDA Medical Device Regulations…
Get It Right the First Time
Medical Device Services
We assess the current state of FDA Medical Device Compliance of your manufacturing and established Quality System with respect to the Federal Regulations.
Special Services
We are available to assist clients with special projects that require expert experience.
Training
Based on our extensive training experience in the FDA Medical Device space, we are available to assist clients with training opportunities.
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Latest News
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A dozen former FDA commissioners blast Prasad’s proposed vaccine policy changes
Drastic overhauls of U.S. vaccine regulations proposed by top United States (US) Food and Drug Administration (FDA) official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the Agency.
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FDA’s QMSR (Quality Management System Regulation) is Live: Expert says new rule may be challenging for smaller firms, combination product makers
Medical device makers must comply with the U.S. Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday, 02 FEB 2026. Additionally, FDA inspections of device facilities will no longer be conducted under the prior Quality System Inspection Technique (QSIT) and instead will be carried out in accordance with a new Compliance Program Manual.
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United States Completes WHO (World Health Organization) Withdrawal
The U.S. Department of Health and Human Services (DHHS) and the U.S. Department of State announced the United States’ completion of its withdrawal from the World Health Organization (WHO) due to the organization’s mishandling of the COVID-19 pandemic that arose out of Wuhan, China, its failure to adopt urgently needed reforms, and its inability to demonstrate independence from the inappropriate political influence of WHO member states.
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FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods
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The Center for Disease Control and Prevention (CDC) updates website to say vaccines may cause autism without new evidence
The Centers for Disease Control and Prevention (CDC) has updated its webpage on vaccines and autism with new claims undermining the Public Health Agency’s longtime position that vaccines do not cause the condition — garnering swift condemnation from public health advocates and the Senate’s top healthcare legislator.