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.
FDA Medical Device Regulations…
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Latest News
When Your Knee Cartilage Wears Out, a ‘Biomaterial’ Might Help Replace It
Biomaterial regenerates cartilage in sheep knee joints: A new biomaterial has shown potential in regenerating high-quality cartilage in sheep’s knee joints, offering a promising treatment for osteoarthritis, according to a study in the Proceedings of the National Academy of Sciences. The biomaterial uses modified hyaluronic acid to create a scaffold that supports cartilage regeneration and could potentially make total knee replacement surgeries obsolete.
Dogs play a key role in veterinary college’s brain cancer trial
Dogs with brain cancer undergo focused ultrasound: Dogs with brain cancer are undergoing histotripsy, or focused ultrasound, at the Virginia-Maryland College of Veterinary Medicine, and what researchers learn from the study may help both dogs and people. Surgery is still a component of the study both because it is the standard of care and so that the ultrasound-treated tumor tissue can be analyzed; however, researchers hope to develop an effective ultrasound technique that does not involve surgery.
Science explores the origins of the friendship between dogs and humans: Recent studies confirm dogs’ ability to understand us, their natural talent for empathizing with other species and the pleasure we get from sharing our lives with them
Various scientific disciplines examine dog-human bond: Brain waves tied to relaxation increase when people walk or play with dogs, according to a study published in PLOS ONE that also connects concentration-linked brain waves to grooming and playing. In addition to the study’s details about the mechanisms of animal-human interaction, science on the 15,000-year-old relationship has proliferated in recent years, incorporating findings from paleobiology, psychology, and neurology.
Autism could be diagnosed with stool sample, scientists say: Researchers found differences in the gut microbes of autistic people, raising hopes for faster diagnosis
Machine Learning (ML) aids in diagnosing autism from stool sample: After using machine learning (ML) to analyze stool samples from children aged one (1) year to 13 years, researchers were able to distinguish autistic individuals from those that are neurotypical with 82% accuracy. This suggests that the microbiome might influence autism expression and offers the potential for new diagnostic tools and treatments, said Qi Su, Lead Researcher of the Nature Microbiology study.
‘I’ve invented an alternative to uncomfortable (pap) smear tests’
Innovation removes invasiveness, pain of pap smears: The Papcup cervical screening device created by Imperial College London postgraduate student Sanziana Foia makes it possible for women to test their menstrual blood for potential signs of cervical cancer without invasive procedures that require appointments at medical offices. The next steps will be “bringing it all together and being able to demonstrate this on the table, raising investment so we can refine the bio-sensor, and down the line clinical trials so we can finally bring this to women as a product,” says Foia.
The brain makes a lot of waste. Now, scientists think they know where it goes
Mouse studies reveal how the brain disposes of waste: Three (3) recent studies in Nature detail the brain’s waste removal functions in mice, demonstrating that during sleep, slow electrical waves stimulate the movement of cerebrospinal fluid that flushes waste from deep regions of the brain to the surface, which is then carried away to the liver and kidneys for disposal. This waste removal system, called the Glymphatic System, removes amyloid and other wastes from the brain, and interventions that enhance brain waste removal might help prevent or treat neurodegenerative disorders.