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

A Federally Qualified Health Center (FQHC) Taps eClinicalWorks Health IT to Boost Population Health:  An FQHC in Connecticut increased HIV screenings by 11 percent after adopting population health modules from health IT vendor eClinicalWorks

HIV screenings rise after health center deploys analytics tool: The use of a Healthcare Effectiveness Data and Information Set analytics solution led to better efficiency and compliance at the Connecticut Institute for Communities, which implemented the system shortly before the COVID-19 pandemic started. HIV screenings have increased by 11% since the federal qualified health center started using the tool.

CDC now encouraging doctors to consider more blood testing for “forever chemicals”:  Known as PFAS, the chemicals are found in myriad consumer products

Center for Disease Control: CDC urges physician to talk with patients about PFAS: New CDC guidance suggests that physicians consider more patient communication and blood testing for per- and polyfluoroalkyl substances (PFAS), or “forever chemicals,” found in many consumer products. Dr. Aaron Bernstein of the National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry estimates that more than 90% of the nation’s population has been exposed to PFAS, whose potential health risks include higher cholesterol, lower infant birth weight, some cancers, pregnancy complications and elevated liver enzymes.

World risks missing deadline for pandemic accord, says WHO chief

WHO urges pandemic deal as “zombie virus” threat looms: World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus has voiced alarm over the number of countries set to miss a May deadline for committing to a global accord on fighting pandemics, warning that “future generations may not forgive us” for failing to act against global disease threats. Separately, scientists are warning that climate change could release ancient viruses trapped in the Arctic permafrost, a pandemic threat they warn is being overlooked

Nearly 1 in 10 teens worldwide have used ineffective and potentially harmful weight-loss products, study estimates

Teen use of OTC weight-loss products a growing concern: About 9% of adolescents worldwide have used over-the-counter drugs, supplements or other products that claim to aid weight loss, researchers reported in JAMA Network Open. Six (6) percent of teens had used diet pills, 4% had taken laxatives and 2% had used diuretics in an effort to lose weight. Past research has tied the use of such products to mental health issues, substance use and eating disorders in teens.

Duke breakthrough:  Transplanted parts of heart are growing along with child:  A year after doctors at Duke Health transplanted some valves and arteries into the heart of a sick child, they announced success on Tuesday in the Journal of the American Medical Association

Partial transplant offers hope for children with heart disease: In 2022, surgeons transplanted living heart valves and arteries into a 17-day-old baby with truncus arteriosus, and the tissues have grown with the child, potentially eliminating the need for future surgeries, according to a report in the Journal of the American Medical Association (AMA). The procedure requires less immunosuppressant medication and could double the number of hearts available for children with heart disease, according to first author Joseph Turek, Chief of Pediatric Cardiac Surgery at Duke Children’s Hospital.

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