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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Latest News
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Management Reviews Should Drive Insight
A Management Review is meant to be one of the most strategic tools in a management system. It brings leaders together to reflect on performance, understand the state of the system, and make changes to benefit the system. Yet, too often, these meetings become predictable. Data is at times “massaged” to give leadership a warm and fuzzy feeling.
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EU Commission proposes major reforms to MDR
The European Commission (EC) has proposed targeted reforms aimed at simplifying rules for medical devices. The proposed reforms are part of a package of measures put forth by the Commission in December 2025 to advance the biotechnology sector, enhance access to cardiovascular treatments, and streamline medical device regulations.
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Moving From Audit Fatigue to Audit Readiness
Every quality professional knows the feeling — that sudden jolt of anxiety when an audit notification hits the inbox. Despite robust systems, documented Standard Operating Procedures (SOPs), and periodic training, many organizations still scramble when Auditors come calling. The truth is simple: audit panic is a symptom, not a cause. It signals a gap between the Quality Management System (QMS) and what is lived daily.
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FDA’s Least Burdensome Approach? Really?
Over the past year, industry has been seeing a pattern in several FDA interactions that are worth talking about openly…one professionals opinion…
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The biology behind mental fatigue: Is your brain tired? Researchers are discovering the roots of mental fatigue. Better ways to measure cognitive exhaustion could point to treatments for long COVID and other debilitating disorders.
Cognitive fatigue is being studied more intensively due to its prevalence in conditions such as long COVID, chronic fatigue syndrome, and multiple sclerosis, with researchers developing better biomarkers, behavioral tools and potential treatments. Leading theories suggest that when the brain engages in sustained, effortful thinking such as complex problem-solving or navigating unfamiliar situations, demands on neural circuits may deplete cellular energy or allow metabolic waste products like glutamate to accumulate, triggering fatigue as a protective signal to rest.
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FDA opens door to massive real-world datasets in medical device submissions
The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions.