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 30 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.
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FDA and Quality Activities
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Latest News
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European Commission publishes implanting regulation on conformity assessments by Notified Bodies
The European Commission in the beginning of May 2026 published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
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FDA Blocks publication of COVID, shingles vaccine safety studies according to the New York Times
In the latest update to COVID and vaccine-related discourse bubbling up at the FDA, Agency officials have recently blocked the publication of several safety studies conducted on COVID and shingles vaccines, The New York Times reported in mid-May 2026.
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FDA Expectations create potential friction in new Form FDA-483 response Guidance
Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year (in 2026) unveiled, for the first time, draft Guidance on best practices for the industry when replying to the receipt of a Form FDA-483, Inspectional Observations.
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Makary stresses urgency to approve new treatment quickly
U.S. Food and Drug Administration (FDA) Commissioner Marty Makary said the Agency should apply the same urgency as it did to approve the first treatments for HIV/AIDS in the 1990s to new drugs and medical devices, including those for Alzheimer’s disease, Type 1 diabetes, and cancer.
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MedCon: Don’t change course based on proposed MDR/IVDR reforms
Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline; however, a speaker at a recent meeting (in Columbus, Ohio) told attendees not to change their priorities based on proposed legislation.
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Notified body group raises safety concerns about targeted MDR<IVDR revision
The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions planned for the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to ease post-market surveillance requirements may compromise patient safety.