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

New prediction tool can determine individual’s 13-year dementia risk at 100% prediction accuracy

A point risk score prediction model that can identify an individual’s risk of developing dementia at 13 years has been developed by researchers in China using diagnostic study data involving 444,695 individuals in the UK. The tool was able to determine 13-year risk for dementia with almost 100% accuracy for both men and women.

Dissolvable tools may hold promise for surgery-free device removal:  MIT study finds new way to dissolve stents, staples – potentially replacing surgical removal

Biomedical devices, such as a drug delivery tool, staples and stents made out of aluminum that dissolve within minutes when exposed to eutectic gallium-indium were developed by a team led by a Mechanical Engineering Assistant Professor at MIT. Researchers noted that further studies are needed to verify the technique’s safety in human applications.

Algorithm measures gait quality to predict fall risk:  New algorithm developed in Australia measures gait quality – mobile app is slated to be released in late 2023

An algorithm that works with a built-in accelerometer in a smart watch to track a user’s gait quality, Watch Walk, has been developed by researchers at the University of New South Wales and Neuroscience Research Australia. The tool measures walking-related factors, such as stride length, cadence, posture and speed, which can aid in determining an individual’s risk of falling.

FDA guidance focus on medical device surveillance, post-approval studies:  FDA finalizes guidances on medical device post-approval studies, post-market surveillance

The FDA has released two final guidances related to medical device post-market surveillance and procedures for handling post-approval studies. The procedures guidance offers recommendations on PAS content and format as a condition of premarket approval, while the surveillance guidance explains the Agency’s interpretation of post-market surveillance orders for certain Class II or Class III devices according to section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Stethoscope app shows promise in tracking heart health:  App turns smartphones into electronic stethoscopes

The Echoes app, which turns a smartphone into a standard stethoscope when placed on a user’s skin, shows promise in monitoring the progress of heart conditions, a study shows. “The results have shown that non-medical users are able to record heart sounds in sufficiently good quality for further processing of the signals. We may be able to extract further features for diagnosis and monitoring purposes in future clinical studies,” said study Author Hongxing Luo.

Questionnaire to predict childhood asthma performs well in study: Noninvasive Test Might Easily Spot Asthma in Preschoolers

A study published in JAMA Network Open revealed that the Childhood Asthma Risk Tool outperformed the Asthma Predictive Index, which requires invasive tests, as well as diagnoses by physicians.