Lori A Carr, Medical Device Specialist

FDA Compliance

Move It Forward

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FDA Compliance Consultant

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.

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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

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.

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Special Services

We are available to assist clients with special projects that require expert experience.

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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

  • Mock FDA Inspections
  • Gap analysis and GMP / QSR review
  • Internal audits / Supplier audits
  • Participation in actual FDA inspections

FDA and Quality Activities

  • Procedure review, rewrite, or creation for compliance with FDA GMPs
  • FDA inspection preparation for routine, PMA, and 510(k) inspections
  • GMP training and other associated FDA training
  • Registration and Listing

Compliance Remediation

  • FDA commitment activities
  • FDA-483 and Warning Letter

Latest News

Brain implants to treat epilepsy, arthritis, or even incontinence?  They may be closer than you think:  Startups around the world are engaging in clinical trials in a sector that could change lives – and be worth more than £15bn by the 2030s

Brain implant dramatically reduces seizures: Oran Knowlson, a teenager with Lennox-Gastaut syndrome, has experienced an 80% reduction in his daytime seizures after becoming the first person to trial a new brain implant called Picostim, which delivers constant electrical signals deep into his brain to block abnormal brain impulses. The latest generation of neural implants not only decode but also regulate brain activity, offering promising treatments for a wide range of conditions including epilepsy, Parkinson’s and brain cancer.

Using AI (Artificial Intelligence) and brain implants, researchers reconned ALS patient with their lost voice

AI (Artificial Intelligence)software, brain implants restore patient’s voice: Researchers have restored the voice of a patient with amyotrophic lateral sclerosis using a brain-computer interface implant and AI-driven text-to-speech software. The study, published in the New England Journal of Medicine, showed the approach achieved an accuracy rate of more than 97% in translating brain signals into speech.

Investors shrug off drug price talks’ effects

Investors unshaken by Medicare’s drug price cuts: Investors have remained calm despite Medicare negotiating a 22% reduction in net spending on some top-selling drugs, with the pharmaceutical industry expected to manage the impact without disruption to profits or drug development. “It’s not surprising to me that the markets haven’t come crashing down, because I think this process was not set up to bankrupt the pharmaceutical industry,” said Aaron Kesselheim, physician and attorney at Harvard.

The Taliban ‘took my life’ — scientists who fled takeover speak out:  Researchers from Afghanistan who found sanctuary around the world following the Taliban takeover in 2021 are struggling to settle in

Scientists who fled Afghanistan try to settle into new lives: Clinical scientist Shekiba Madadi left Afghanistan after the Taliban took power and began suppressing research and oppressing women, and she is now in the United States pursuing a medical degree and working at a private cardiac treatment center. Another female scientist, who asked to remain anonymous to protect her family in Afghanistan, says that the Taliban took away her life, and despite facing severe limits due to her nationality, she was able to obtain a position in fetal medicine in the US and organizes virtual training sessions for young women who have been blocked from medical schools in Afghanistan.

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.