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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Biofilm Bacteria May Fuel Heart Attacks: Evidence from autopsies and surgical patients suggested that oral bacteria can infiltrate hardened arteries and trigger immune responses tied to heart attacks
Oral bacteria linked to heart attack risk: DNA from oral bacteria was found in a significant portion of arterial plaques from sudden death victims and surgical patients, and when activated by external triggers, these bacteria may provoke immune responses that contribute to plaque rupture and the onset of myocardial infarction, according to a study in the Journal of the American Heart Association. The findings highlight both the potential for biofilm-targeted therapies to prevent heart attacks and the importance of oral hygiene in cardiovascular health.
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From heart to skin to hair, ‘Replaceable You’ dives into the science of transplant
From pig organs to 3D printing: The future of transplants – Science writer Mary Roach’s latest book, “Replaceable You: Adventures in Human Anatomy,” explores the history and future of replacing human body parts, from 16th-century prosthetic noses to modern advances in gene editing and 3D-printed tissue. Roach traces how pigs became the standard model for organ transplants, why genetic editing is crucial to reduce rejection and how scientists are working to print muscle that mimics natural structures.
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Inflammation During Pregnancy May Prime Offspring for Anxiety
Mouse study shows that maternal inflammation linked to long-term anxiety risk in offspring: A study with mice showed that that prenatal inflammation or stress during pregnancy can trigger epigenetic changes in specific neurons in the offspring’s hippocampus, leaving them primed for anxiety-like behaviors in adulthood. Researchers say these findings link prenatal adversity to lasting brain changes and may guide the search for early biomarkers and new treatments.
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Women’s healthcare chronically underfunded, say Melinda French Gates
Melinda French Gates pledges another $50M for women’s health: Melinda French Gates has committed an additional $50 million to women’s health research through Pivotal Ventures and Wellcome Leap. The funding will be used to address areas such as autoimmune conditions, cardiovascular disease, and mental health. “Women’s health is chronically underfunded, chronically under-researched, and, as a result, not well understood,” French Gates said.
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Amphetamine users get higher with a little help from microbial friends
Amphetamines can be extremely helpful for people with certain neuropsychiatric conditions, such as ADHD. However, they are also frequently misused and abused, creating a growing public health problem. There are currently no medicines for treating amphetamine use disorder, but hope may be on the horizon: Researchers have zeroed in on how a common microbe enhances the effects of these drugs — which means they might someday be able to do the opposite.
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FDA Launches Crackdown on Deceptive Drug Advertising
The U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) announced on 09 SEP 2025 sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. The FDA sent thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.