President and CEO of Lori A. Carr, Inc., is a Principle Consultant in the Medical Device regulated industry.
Lori has more than 26 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 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. She has created and implemented quality 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.
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
FDA Medical Device Regulations...
Get it right the first time.
October 14, 2021
Lori A. Carr, RAC (US), CQA (ASQ), RABQSA
Dear Ms. Carr:
Vista LifeSciences, Inc. is very appreciative of the work that you continue to do in support of our FDA regulatory efforts. Our company has been working on our regulated product listings and 510(k) applications for medical devices since 2010. We have engaged other consultants, some from large companies. It was not until your engagement in the past two years that we have the appropriate advice, guidance, and counsel during reviews and internal audits that we have what we need.
We have specifically benefited from your guidance on FDA required documents, in particular SOPs. Your ability to suggest "how" the FDA might review and question our procedures gives us better insight into how and why something should be written in a specific way. Your guidance regarding “best practices” has been invaluable as we implement improvements. You have been able to attend calls with FDA reviewers and help us understand their guidance and questions during the interactive review of our most recent 510(k) application. And lastly, you help balance us between writing too much vs. too little, enabling an efficient but effective set of documentation required for approval and appropriate for our next inevitable compliance inspection.
With your support, we now have more confidence in our Quality System processes and documentation. Most importantly, your guidance allowed us to successfully navigate our most recent pre-market notification and subsequent interactive review that resulted in being awarded 510(k) Clearance of our Class II Software as a Medical Device product.
Feel free to have prospective customers contact us if you want a recommendation. We have enjoyed the engagements so far and will continue to use your services when needed.
S. Michael Lutz
COO and CTO, Vista LifeSciences, Inc.