FDA 510k Consultant Team

Below you will find biographies and contact information for our FDA 510k consultant team, the human factors team, and the sales team.

Quality Assurance & Regulatory Affairs Consulting Team Services

Our consulting team offers services in three key areas:

1. Regulatory Submissions (e.g., Breakthrough Device Designations, 513(g) submissions, Pre-Submissions, 510k submissions, Human Factors Documentation, De Novo Applications, CE Marking Technical Files, and Canadian Medical Device License Applications)
2. Regulatory Compliance (e.g., mock FDA inspections, ISO 13485 certification, and CAPA)
3. Continuing Education Training – webinars, public and private in-house training courses.

To learn more about our consulting team and the services we provide, to schedule a call, or to request a proposal, please contact Lindsey Walker, Director of Sales, at +1.802.989.3939 or by email at lindsey@medicaldeviceacademy.com.

Medical Device Academy has grown over the years, and we are continuously adding new experts to our team. Interested in Joining our Team? Click Here for Consulting Opportunities.

Our FDA 510k Consulting Team, Human Factors Team, and Sales Team

We have seven (6) full-time employees. Two employees are qualified lead auditors, and we have a team of subcontractors that include additional qualified lead auditors. Our permanent, full-time employees are listed below in the order that they joined our team. The titles for our FDA 510k consultants are based upon the number of 510k submissions they have submitted and were successfully cleared–not the years of experience. Consultants with five (5) or more cleared 510k submissions are Sr. Regulatory Consultants, and consultants with less than five (5) cleared 510k submissions are Associate Regulatory Consultants.

Tifany Chesser – Human Factors Team

Tifany is an Executive Admin for Medical Device Academy. She reports to Matthew Walker on the Human Factors Team, she is responsible for scheduling meetings with the President, and she assists the sales team with data entry. She also helps with the preparation of 510(k) submissions and pre-submissions.

Email | tifoncomp@msn.com Tel | (802) 779-4897

Matthew Walker – Human Factors Engineering | Risk Management | Cybersecurity & DFIR

Matthew came to us with a regulatory background focused on OSHA and NFPA regulations from his time as a Firefighter/EMT and Rope Rescue Tech. Since we “kidnapped” him from his other career the better part of a decade ago, he has taken on the role of a Technical/Medical Writer and Lead Auditor. He has worked extensively with Quality Management Systems and developed a strong affinity for Risk Management and Human Factors Engineering. Matthew holds an Associate’s Degree in Fire Science with Honors from Keiser University, where he was a member of both the Golden Key and Phi Theta Kappa Honor Societies. He was also a published controbutor to the International Society of Fire Service Instructors (ISFSI).

Most recently, in August of 2025, Matthew Graduated Summa Cum Laude from Champlain College in Vermont with a 4.0 GPA in Computer Forensics and Digital Investigations. There he discovered an interest in destructive testing and reverse engineering of Bluetooth-connected devices. His is a member of Omicron Sigma Sigma’s Order of the Sword and Shield Honor Society for protective service disciplines, as well as the Alpha Sigma Lambda and Omega Sigma Nu honor societies. He also claims that he “probably isn’t the worst Python coder, but no garuantees” and is around A2 in French on a good day. When he’s not indulging in his “mad scientist” side side, Matthew explores his other passion, the culinary arts. He is a certified butcher and founder of the Vermont nonprofit Boarding Axe Kitchen, which prepares meals for food shelf distrobution. You may catch him on LinkedIn or one of his several Youtube channels.

Email | matthew@fdaestar.com Tel | +1.802.342.1446

To schedule a call with Matthew regarding auditing or human factors projects, please email him directly to schedule an appointment.

Lindsey Walker – Sales Team

Lindsey Walker studied at Castleton University, way back when it was just a little old Castleton State College in Castleton, Vermont, where she received her BS in Business Marketing. She also studied at North Country Community College, where she received her Certificate in Practical Nursing. Besides preparing proposals and sending out invoices, Lindsey was recently promoted to Director of Sales. In this new position, she is responsible for managing the sales team, coordinating introductory calls with our clients, creating proposals, and managing our new billing clerk. Lindsey loves cars, but when she is not behind the wheel of one, you can find her on a pottery wheel.

Email | lindsey@medicaldeviceacademy.com Tel | (802) 989-3939

You can schedule a call with Lindsey using her zoom booking link.

Alysha Chesser – Sales Team

Alysha (a.k.a. – Assassin Sylvia) is our social media marketing expert and gamer extraordinaire. She makes sure we deliver helpful new content every week to our blog and YouTube subscribers. She helps our team announce new live webinar training courses and the release of new and updated procedures via email. Each month Alysha also selects one procedure that will be eligible for the “Alysha” 50% discount.

Shaily Shah – FDA 510k Consultant Team