Device consulting team for regulatory submissions and compliance

20190616 133400 e1561168984239 225x300 Device consulting team for regulatory submissions and compliance

Father’s Day 2019

Our regulatory consulting team provides regulatory consulting services to medical device manufacturers regardless of size and location. Our team is global and we routinely handle medical device regulatory issues around the world.

Consulting Team Services

Our consulting team offers services in three key areas: Icons 103x300 Device consulting team for regulatory submissions and compliance

  1. Regulatory Submissions (e.g., 510k submissions, CE Marking and Canadian Medical Device Licensing)
  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 Rob Packard, President at +1.802.281.4381 or by email at rob@13485cert.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

Founder & President

Pix Rob Packard zoom 150x150 Device consulting team for regulatory submissions and complianceRob Packard – QMS & Regulatory Consultant

Rob is the founder and President of Medical Device Academy. The company was incorporated in October of 2013, but he wasn’t smart enough to get some full-time help until 2016. Rob is constantly doing everything to extremes. That includes Zoom meetings with Austria, Sweden, Netherlands and Israel at 6am; and Skype calls with China and Australia and 10pm. He of course “balances” this out with two and three workouts a day, and a good novel until midnight. The picture above shows Rob at the end of a training hike with his dad (77 years old). I wonder where he gets his extreme personality from?

Email: rob@13485cert.com Phone: (802) 258-1881

Full-time & Part-time Employees

Mary Head Shot 150x150 Device consulting team for regulatory submissions and complianceMary Vater – 510(k) Consultant

Mary is a biomedical engineer and consultant with Medical Device Academy. 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 and standalone software. She also has experience with CE Marking and Canadian Licensing application. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.

Email: mary@fdaecopy.com Phone: (913) 274-9899

Photo of Tifany Walker Chesser 150x150 Device consulting team for regulatory submissions and complianceTifany Chesser – Executive Admin.

Tifany is the Executive Administrator for Medical Device Academy, Inc. and FDA eCopy. She is responsible for scheduling meetings with the president and other consultants on the team. She also helps to prepare 510(k) submissions and pre-submissions–including the printing of FDA eCopies and ensuring they are picked up by FedEx on-time.

Email: tifoncomp@msn.com Phone: (802) 779-4897

20190531 005146 150x150 Device consulting team for regulatory submissions and complianceMatthew Walker – QMS, Risk Management/HFE

Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Systems and Regulatory Pathways. He is a Junior in George Washington Universities BSHS- Clinical Research Management Program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. 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

Connect on Linkedin:http://www.linkedin.com/in/matthew-walker-214718101/

20190519 104052 150x150 Device consulting team for regulatory submissions and complianceLindsey Walker – Sales, QMS & Submissions

Lindsey Walker studied at Castleton University, way back when it was just 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 working with quality systems Lindsey is an executive assistant and she is training for a larger sales and marketing role in the company. Lindsey, loves cars, but when she is not behind the wheel of one you can find her on a pottery wheel.

Email: sales@medicaldeviceacademy.com

selfie 300x252 Device consulting team for regulatory submissions and complianceEthan Baker – IT, Digital arts, Video Production

Ethan Baker is our team’s IT specialist and digital arts management technician. A graduate of Stafford Technical Center’s Visual and Multimedia Production, Ethan is the video editor responsible for sharing Rob’s soothing melodic voice featured in many of our YouTube videos and webinar trainings. When not directing our next cinematic masterpiece, Ethan runs Silverfang Entertainment streaming on Twitch and YouTube.

 

Independent consultants we work with

Leo Eisner – IEC 60601 Expert

35ebc9d 150x150 Device consulting team for regulatory submissions and complianceLeo is the Principal Consultant of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, an expert in product safety for medical electrical devices (IEC 60601 series of standards), has been heavily involved in standards development focused on the IEC 60601 series of standards including working on IEC 60601-1, 3rd ed. + Amendment 2 (due out late 2019), has worked for several Notified Bodies as an auditor & technical reviewer, and is an expert in CE marking for the medical device directive.  He has over 30 years experience in product safety, and he routinely speaks all over the world as an international expert on the topic of electrical safety and IEC 60601-1. Read More

 

Head Shot from LinkedIn for Wolfgang Huber 150x150 Device consulting team for regulatory submissions and complianceWolfgang Huber & Yves BerquinHead Shot from LinkedIn for Yves Berquin Device consulting team for regulatory submissions and compliance

Wolfgang Huber and Yves Berquin are Co-Founders of Matrix Requirement Medical. They are software engineers experienced in the requirements for IEC 62304 and the requirements for software documentation in a 510k submission. Their company developed a web-based application to help medical devices organize documentation (requirements, specifications, use cases, tests, risk analysis) for their Design History File (DHF). The software eliminates the need to exchange word documents, maintains version control and automatically creates a traceability matrix. The company website includes testimonials for customers that use the software for creating their 510k submission documents.

Emails: wolfgang@matrixreq.comyves@matrixreq.com