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 (7) full-time employees. Three 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 Team

Matthew came to us with a regulatory background focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he was recently promoted to manage our human factors team as Branch Chief of the Human Factors Division. He is a Junior at Champlain College in Burlington, Vermont, where he specializes in Computer Forensics and Cybersecurity. Matthew participates as a member of our audit team and is passionate about risk management, human factors engineering, and cybersecurity. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts, as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.

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 our Calendly app.

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.