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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How to Navigate the Triad of Audits in Medical Device Compliance
MDR (the European Union [EU] Medical Device Regulation), MDSAP (the Medical Device Single Audit Program), and FDA Inspections demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market access.
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FDA relaxes oversight of general wellness devices, Clinical Decision Support (CDS) software
In a move meant to bolster the adoption of Artificial Intelligence (AI)-enabled digital health products, the US Food and Drug Administration (FDA) in January 2026 updated two guidance documents to ease its oversight of general wellness devices and Clinical Decision Support (CDS) software.
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IMDRF (International Medical Device Regulators Forum) emphasizes engagement, governance reform in new strategic plan
The International Medical Device Regulators Forum (IMDRF) has outlined its vision for the next five (5) years, which includes further engagement with the medtech industry to ensure promising products reach patients quickly. The group also plans to reform its governance structure as it continues to grow its membership to ensure long-term sustainability.
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Study identifies eight (8) distinct paths or long COVID symptoms
A study in Nature Communications found that long COVID follows eight (8) symptom trajectories, varying in severity and duration. Researchers tracked 3,700 adults and found 10% developed long COVID, with 81% of those still having symptoms a year later. “The variability we identified will enable future studies to evaluate risk factors and biomarkers that could explain why patients vary in time of recovery, and help identify potential therapeutic targets,” said lead researcher Tanayott Thaweethai.
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Can you fight cancer with cancer? A CSU scientist is trying to find out: Colorado State University (CSU) Professor Raymond Goodrich has developed a cancer immunotherapy that uses a patient’s own tumor cells to train the immune system
Personalized immunotherapy enters human trials: A personalized immunotherapy developed at Colorado State University (CSU) that extended the life of a dog with cancer is set to begin human trials. The immunotherapy uses a patient’s own inactivated tumor cells to train the immune system to recognize and attack the cancer, and a clinical trial at City of Hope in California will involve patients with recurrent ovarian cancer.
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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.