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…
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.
Ask us about your projects
If you would like to contact us about helping with your current Quality/Regulatory project, please complete the form below.
Step in the Right FDA Direction
Quality System Assessment
FDA and Quality Activities
Compliance Remediation
Latest News
Scientists Spot Which Gut Germs Trigger Compulsive Eating
Gut bacteria may bacteria may be linked to food addiction: Researchers found that an abundance of Proteobacteria in the gut is linked to food addiction in both humans and mice, while higher levels of Blautia and Actinobacteria appear to have protective effects against this condition. The findings, presented at the Federation of European Neurosciences Societies meeting and published in Gut, highlight the potential for manipulating gut microbiota to treat food addiction and related eating disorders.
First Radioactive Rhino Horns To Curb Poaching In South Africa
Radioactive chips may protect rhinos from poaching: Scientists in South Africa injected tiny radioactive pellets into the horns of twenty (20) live rhinoceros in an antipoaching project led by the University of the Witwatersrand’s Radiation and Health Physics Unit. The radioactive chips will not harm the environment or the rhinos’ health; however, they will render the horns useless for human consumption and will make them easier to detect at borders, airports, and harbors
Will it soon be possible for doctors to use AI to detect and diagnose cancer?
AI (Artificial Intelligence) detects 13 cancer types with 98.2% accuracy: An AI model, EMethylNET, was 98.2% accurate in detecting 13 cancer types and other non-cancer samples using DNA data from tissue samples, researchers reported in the journal Biology Methods and Protocols. “Depending on the availability of training data, this method can be extended to detect hundreds of cancer types,” researchers said.
World’s 1st epilepsy implant cuts seizures by 80%, recharges via headphones: Seven months post-operation, Oran has been reported to be “more alert and has not experienced any drop seizures during the day.”
Brain implants significantly reduces boy’s severe seizures: A young patient with Lennox-Gastaut Syndrome (LGS), a treatment-resistant form of epilepsy, is the first to receive a neurostimulator implant to control seizures. The device sends electrical signals deep into the brain and appears to have lessened the boy’s severe daytime seizures by at least 80%.
Bionic leg moves like a natural limb — without conscious thought: Computer interface links signals from the brain to an artificial limb, giving the wearer better balance, flexibility and speed.
Bionic leg enables amputees to walk naturally and faster: A bionic leg that boosts brain and spinal cord signals has enabled seven amputees to walk 41% faster than those with standard robotic prosthetics, with peak speeds comparable to those without amputations, offering a more natural walking experience for amputees. “This is the first study that demonstrates natural gait patterns with a full neural modulation where the person’s brain is 100% in command of the bionic prosthesis, not a robotic algorithm,” said Hugh Herr, Co-Author of the study in Nature Medicine.
US FDA recommends steps to improve diversity in clinical trials
FDA issues draft guidance for clinical trial diversity: The FDA is accepting comments on draft guidance suggesting ways that drugmakers and medical device makers can improve diversity in clinical trial participant pools. Goals for a “diversity action plan” should consider the estimated prevalence of the target disease, and the agency will require most makers of new drugs and devices to submit clinical trial diversity plans.