Lori A Carr, Medical Device Specialist

FDA Compliance

Move It Forward

Regulatory Affairs Certification US logo
Regulatory Affairs Certification logo
ASQ logo
Exemplar logo

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.

MRI

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.

Special Services Icon

Special Services

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

Training Icon

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

Cinnamon applesauce investigation finds lead levels more than 2,000 times higher than proposed standards, FDA says

Food plant inspections reveals high lead contamination: An FDA inspection of a food production plant in Ecuador uncovered lead levels more than 2,000 times above proposed standards. Contaminated cinnamon in applesauce products that were made there and sold under three (3) US labels have been linked to at least 65 cases of illness in children younger than 6 years.

Smartwatches Are Spotting Hidden Heart Trouble in Kids

Using smartwatches for heart issue detection in children shows promise: A study published in the journal Communications Medicine found that using smartwatches to detect arrhythmias in children is feasible, and medical records show the tools were able to detect heart issues that were not spotted using traditional monitoring approaches. Researchers wrote that it may be useful for children to have smartwatch technology with heart-tracking algorithms designed for their age group.

How studying arctic ground squirrels can help advance human brain health

Unlocking squirrels’ hibernation secrets for brain health: Arctic ground squirrels’ ability to hibernate in freezing conditions for long periods has prompted researchers to develop drugs that mimic hibernation and slow the metabolic rate in humans, which may be effective in treating brain injuries or neurodegenerative diseases. Researchers are working on a drug that stimulates A-1 receptors, which have been found to slow metabolism in squirrels, with promising results in studies with rats and pigs.

CPAP Device for Sleep Apnea Might Also Ease Chronic Cough, Heartburn

Heartburn, chronic cough relief linked to CPAP device use: A study in the journal ERJ Open Research found that patients with sleep apnea who used a continuous positive airway pressure device regularly had 42% lower odds of experiencing nighttime heartburn at a follow-up period of two (2) years compared with patients who used the machine a little or those who did not use one at all. The acid reflux reduction was associated with an almost fourfold reduction in chronic bronchitis risk and at least a fourfold decrease in morning cough with mucus.

FDA clears Daye’s gamma-irradiated Nude tampon:  Daye is disrupting the women’s health space; its organic tampon is passed through gamma rays which reduce the risk of vaginal infections

Gamma ray-sanitized tampon cleared as medical device: The FDA has cleared the Nude Tampon from Daye, allowing the tampon to be marketed as a medical device. The organic tampon has been sanitized via gamma ray to reduce the risk of toxic shock syndrome and other vaginal infections.