Device consulting team for regulatory submissions and compliance

Pix Rob Packard zoom 297x300 Device consulting team for regulatory submissions and compliance

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

Full-time & Part-time Employees

Mary Vater 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

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Matthew Walker – Marketing & Sales

Matthew is the newest member of the team for Medical Device Academy, Inc. and FDA eCopy. He is helping us market our consulting services and to promote the Amsterdam 510k workshop. He is also a trained EMT, volunteer fire fighter and OSHA consultant. If you are interested in co-branding or advertising opportunities with our company, please contact Matthew.

 

Email: dragonslayerfirefighting@gmail.com

 

 

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

 

 

Nancy Knettell – Software Verification & Validation Expert

nancydone 150x150 Device consulting team for regulatory submissions and complianceNancy Knettell is a IEC 62304 software verification and validation expert. She added 11 new software verification and validation procedures and associated templates to Medical Device Academy’s growing library of quality system proceduresRead 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

 

adam headshot 240x300 150x150 Device consulting team for regulatory submissions and complianceAdam Shames – Founder & CEO of Core human Factors, Inc.

Adam is a human factors expert. He has an M.B.A. in International Business from the Fox School of Business and Management at Temple University and a B.S. in Human Factors Engineering and Psychology (double major). From Tufts University. He has over a decade of extensive research experience, and has conducted hundreds of usability studies with thousands of participants around the world. He has also been the principal investigator on numerous successful IRB reviewed studies. As a guest speaker, Adam will be explaining how to design and conduct human factors studies for your 510k submission.

Email: shames@corehf.com

 
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Jonathan C. Bretz – UDI Expert 

Jonathan C. Bretz, OT/L, MBA, RAC is a UDI Consultant, and has 35+ years medical device experience, including Regulatory Affairs/Compliance, Submission experience [510(k), CE Technical Files, Health Canada], Quality Systems (QSR, ISO 13485), Risk Mitigation (ISO 14971), Regulatory Strategies, UDI/GTINs, Product Development, Marketing & Sales, Operations and Supply Chain Management. Read More

 

 

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Brigid Glass- QMS Expert

Brigid Glass is a Quality Management Systems consultant who resides in New Zealand. She is a lively and passionate trainer who specializes in coaching smaller medical device companies to build Quality Management Systems (QMS) for compliance with ISO 13485, ISO 14971, the 21 CFR 820 (FDA QSR), and other international regulatory requirements. Read More

 

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Marcus Gould – CE Marking & EU Registration Expert

Marcus specializes in pre-market CE Marking applications and registration of medical devices in the EU. He also has extensive expert knowledge with regard to post-market interactions with Notified Bodies and Competent Authorities regarding vigilance reporting of adverse events. He holds a doctorate in biochemistry (microbiology) from the University of Oxford, holds both Chartered Biologist and Chartered Scientist status, and is a consultant editor for TOPRA’s monthly publication ‘Regulatory Rapporteur’. Read More

 

lena Huerlimann Device consulting team for regulatory submissions and complianceLena Huerlimann- Auditing Expert

Lena R Huerlimann has 18 years QC/QA/RA experience in pharmaceuticals and medical devices. Her auditing expertise includes GMP/GLP/GCP environments, as well as ISO 13485/ISO 9001/ISO 15378 facilities. Read More

 

Allison Komiyama 150x150 Device consulting team for regulatory submissions and complianceAllison C. Komiyama, PhD – 510k & PMA Expert

Dr. Allison Komiyama is the Principal consultant of AcKnowledge Regulatory Strategies.  She is a former FDA reviewer with expertise in medical device and combination product submissions.  While working at FDA in the Office of Device Evaluation, she acted as a lead reviewer and consult on 510k Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her additional specialty was in biocompatibility requirements for implanted devices. She can help your company with a regulatory plan, and your FDA submissions. Read More

 

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Leo Lagrotte – FDA Inspection Expert

Leo J. Lagrotte-former Medical Device FDA Investigator -Leo served 20+ years experience with the FDA and USDA in a number of capacities as an FDA investigator, Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005, and also served on FDA’s Medical Device Inspection Cadre. Read More

 

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Jon Speer – Design Control Expert

Jon Speer is a medical device veteran with more than 16 years experience. Jon specializes in helping medical device start-up companies with design project management. His experience with start-ups gave him the idea to develop a software solution to help companies document Design Controls. Read More

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