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 29 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.
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Latest News
New “smart bandages” hold potential for revolutionizing the treatment of chronic wounds: Researchers at the Keck School of Medicine of USC are co-leading an effort to develop advanced electronic bandages and other tools to improve chronic wound monitoring and healing.
Smart bandages can detect infection, inflammation: Researchers are developing smart bandages capable of autonomously monitoring wound healing and detecting issues like infections and inflammation, according to a study published in the journal Nature Materials. The findings showed potential results in animal models, suggesting these high-tech dressings could revolutionize wound care by assisting in real time, delivering treatments and improving patient outcomes.
Older Women Are Different Than Older Men. Their Health Is Woefully Understudied.
Experts call for more research on older women’s health: Scientific research on older women’s health is “completely inadequate,” leaving clinicians unsure of how well or even whether drugs tested on men in clinical trials will affect postmenopausal women, who are biologically different, says Stephanie Faubion, Director of the Mayo Clinic’s Center for Women’s Health. Experts say more research is needed on heart disease, brain health, mental health, cancer, and bone health in older women, and the White House’s new Women’s Health Initiative might narrow some of these research gaps.
Pet Care Industry Is Dreaming of Dog and Cat Ozempic
Some companies want to adapt weight-loss drugs to pets: Overweight cats lost at least 5% of their body weight within 112 days after receiving an implant containing a glucagon-like peptide 1 agonist, the active ingredient in new human weight-loss drugs, according to Okava Pharmaceuticals, which is developing the implant designed by Vivani Medical. Better Choice, which acquired Aimia Pet Healthco, is also developing pet treats that replicate the benefits of human weight-loss drugs. Although pet obesity is a problem, it is frequently due to overfeeding, and veterinarian Jeanne Ficociello says it is best to try diet and exercise and to check for underlying endocrine disorders before turning to weight-loss drugs for pets.
New insights into the brain regions involved in paranoia: Through a novel approach, Yale researchers translate data from monkeys to better understand how paranoia arises in the human brain.
Regions of brains linked to paranoia found in humans, non-human primates: By comparing data from humans and non-human primates, researchers identified specific regions of the brain involved in paranoia, finding that lesions in these areas were associated with negative behaviors linked to paranoia, according to a study in Cell Reports. Scientists hope that this research could translate to other species, like mice or invertebrates, and could ultimately help find treatments for paranoia in humans.
How personalized cancer vaccines could keep tumors from coming back: The same mRNA technology that quickly brought the world a vaccine for COVID-19 is now showing promise as a bespoke therapy for cancer.
Personalized cancer vaccines show promise in preventing melanoma recurrence: As part of a 2020 clinical trial, melanoma patients had their tumors surgically removed and received a personalized mRNA vaccine that targeted their cancer to prevent recurrence, with three-year results from Moderna and Merck showing reductions in the risk of recurrence and life span extension. The drugmakers are conducting additional vaccine trials that address other cancers, which is made possible using Moderna’s “single use personalized RNA+” machine that churns out mRNA encoding up to 34 cancer mutations selected by AI.
This new brain-mapping device could make neurosurgery safer
Flexible film that senses neural activity to allow for safer neurosurgeries: Researchers have developed a flexible film embedded with microsensors that could be placed over the brain’s surface to detect neural activity, providing resolution that’s 100-times better than current technology and allowing for improved functional brain mapping for safer brain surgery. Researchers are developing a wireless version that could allow for better epilepsy monitoring and ultimately hope to use this technology as a brain-computer interface to aid people who are paralyzed.