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: Icons 103x300 FDA 510k Consultant Team

  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 ten (10) full-time employees and one (1) part-time employee. Five employees are qualified lead auditors, and one is in training. We also have a team of four (4) subcontractors that are 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 that 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.

%name FDA 510k Consultant TeamMary Vater, Consulting Partner – FDA 510k Consultant Team

Mary is a biomedical engineer and consultant with Medical Device Academy. She recently celebrated her 6th anniversary with our firm, and she was promoted to Consulting Partner. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices, artificial intelligence, and Software as a Medical Device (SaMD). She also has experience with FDA De Novo Classification Requests, CE Marking, and Canadian Licensing applications. She served as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.

Email | mary@fdaecopy.com Tel | (913) 274-9899

You can schedule a call with Mary using our Calendly app.

Photo of Tifany Walker Chesser 150x150 FDA 510k Consultant TeamTifany 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

20190531 005146 150x150 FDA 510k Consultant TeamMatthew 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@fdaecopy.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.

20190519 104052 150x150 FDA 510k Consultant TeamLindsey 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 150x150 FDA 510k Consultant TeamAlysha Bellarouse – Human Factors 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 with announcing new live webinar training courses and the release of new and updated procedures, and each month she picks a new procedure or webinar that will be eligible for the “Alysha” 50% discount. She can be reached via email.

%name FDA 510k Consultant TeamSharon Morrow FDA 510k Consultant Team

Sharon is an experienced quality system and regulatory consultant with Medical Device Academy. She joined the company as a Sr. Regulatory Consultant in August 2020. She graduated from Tusculum University with a major in  Business Management, and she has more than 25 years of experience in quality assurance and regulatory affairs. Sharon has experience with 510k submissions for a variety of device product classifications. She also has experience with CE Marking and Canadian Licensing applications. Her previous experience includes 23 years in various quality and regulatory roles at DeRoyal.

Email | sharon@fdaecopy.com  Tel | (865) 705-4400

You can schedule a call with Sharon using our Calendly app.

Photo of Bhoomika 150x150 FDA 510k Consultant TeamBhoomika Joyappa FDA 510k Consultant Team

Bhoomika joined Medical Device Academy as an Associate Regulatory Consultant in April 2021, and she was recently promoted to a Sr. Regulatory Consultant. She has a Master’s Degree in Biomedical/Medical Engineering from The City University of New York. Before joining Medical Device Academy, she worked as a regulatory affairs intern and completed a training program in regulatory affairs at Duke University School of Medicine. She also has previous experience as a SAS programmer and technical writer for Huawei. She is passionate about regulatory affairs, and she is making an immediate positive contribution to our clients by already completing her first few 510k submissions and developing cybersecurity checklists for our clients to help with cybersecurity documentation required by the FDA.

Email | bhoomika@fdaecopy.com  Tel | (201) 290-2613

You can schedule a call with Bhoomika using our Calendly app.

Screenshot 20230107 152405 e1673123405407 150x150 FDA 510k Consultant TeamBecca Taylor – Sales Team

Becca joined Medical Device Academy as a Billing Clerk in September 2022, and she was promoted to Sales and Marketing Executive Assistant. She is working toward her Associate of Science Degree in Health Information Technology from Peirce College. Becca should be your primary contact for any billing issues, questions about proposals, help with user fee payments, help with registration and listing updates, and FDA US Agent services.

Email | becca@medicaldeviceacademy.com  Tel | (253) 329-1492

%name FDA 510k Consultant TeamWonde Tekolla – FDA 510k Consultant Team

Wonde joined Medical Device Academy as an Associate Regulatory Consultant in January 2023. He has a Master’s Degree in Microbial Biotechnology from North Carolina State University and Bachelor’s Degree with a double-majored in Business Management & Health Science (with a Chemistry concentration) from Guilford College. Before joining Medical Device Academy, he worked as a quality assurance and regulatory affairs specialist for two years at Mehtra, LLC. He has prior regulatory experience with pre-submissions, 510k submission projects, and CE Marking Technical Files. He also has experience with quality system implementation for 21 CFR 820, ISO 13485, and MDSAP.

Email | wonde@fdaecopy.com  Tel | (919) 903-0194

You can schedule a call with Wonde using our Calendly app.

Founder & President

Rob Packard 150x150 FDA 510k Consultant TeamRob Packard – FDA 510k Consultant Team

Rob is the founder and President of Medical Device Academy. He manages the FDA 510k Consulting Team. The company was incorporated in October 2013, but he wasn’t smart enough to get some full-time help until 2017. Rob is constantly doing everything to extremes. That includes Zoom meetings with Austria, Sweden, Netherlands, and Israel at 6 am; and Skype calls with China and Australia and 10 pm. He “balances” this out with two and three daily workouts and a good novel until midnight. The picture below shows Rob at the end of a training hike with his dad (77 years old at the time). I wonder where he gets his extreme personality.

20190616 133400 e1561168984239 225x300 FDA 510k Consultant Team
Father’s Day 2019

Email | rob@13485cert.com Tel | (802) 258-1881

You can schedule a call with Rob using our Calendly app.

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