Regulatory

The world of medical device regulations is constantly changing. Our experts can ensure you're equipped with the tools needed to understand, navigate, and apply medical device regulations in an increasingly connected world.

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Regulatory

Practical Post Market Surveillance for Medical Devices (Sep 2024)

Sep 23 to Sep 26, 2024

Regulatory

Navigating 510k & DeNovo Requirements (Nov24)

Nov 12 to Nov 15, 2024

Regulatory

Practical Post Market Surveillance for Medical Devices

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Quality Systems and Risk Management

Combination Products and Regulations: a Risk-Based Approach

Join industry-renowned instructor Susan Neadle to deepen your understanding of the ever-evolving regulatory landscape of combination products, including navigating and applying requirements and recommendations from 21 CFR Part 4, and TIRs 48 and 105, as well as gain familiarity with interpretations within the emerging global marketplace. 
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Regulatory

Navigating 510k & De Novo Requirements

Learn to Identify when a 510(k) submission is required by the U.S. Food and Drug Administration, what medical devices are exempt from review, the various 510(k) submission types, and the processes for submitting 510(k) applications.
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Regulatory

Lead Auditor for Management Systems & Processes

Benefit from the expertise and rigor of AAMI faculty as you learn today’s best practices for conducting internal audits and supplier audits for regulatory compliance.
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Faculty

Pooja Kartik

Rob Packard

Rob Packard is the founder and President of Medical  Device Academy—a full-service quality and regulatory consulting firm with 12 employees. Rob earned his degree in Chemical Engineering from the University of Connecticut @ Storrs. Prior to Medical Device Academy, Rob worked for 10 years in the pharmaceutical and biotechnology industry in research and development of new drug products and biologics.

Jack Ward

Jack Ward is a recognized quality assurance and regulatory affairs professional with over 40 years’ experience in the medical device industry. Jack has held a broad range of corporate management, engineering and Quality/Regulatory positions with direct experience across a broad range of medical device types, technologies and applications. Jack’s company, Ward Sciences and Consulting LLC, provides consulting expertise to medical device companies for regulatory submissions, Quality Management System implementations and audits, remediations and training. 

Mary Vater

Mary Vater is a Medical Device Consultant at Medical Device Academy. Mary earned her degree in Biomedical Engineering from Wichita State University. Prior to Medical Device Academy, Mary served time in both Engineering and Quality roles at Biomedical Devices of Kansas and was a Regulatory Strategist at Cerner Corp. At Medical Device Academy, Mary assists companies in both Quality and Regulatory assignments. Mary has worked on over 30 devices’ 510(k) clearances and has participated in countless Pre-Submission meetings with the FDA. Mary’s experience spans many different technologies including SaMD (Digital Health, Mobile Apps, AI/ML Contouring, Computer Aided Detection/Diagnosis/Triage), In Vitro Diagnostic Devices, Reprocessed Devices, Electromechanical Devices, Implants, Dental Products, Surgical Planning, Surgical Tools, and more. Mary is an expert in Medical Device Quality Management Systems and serves as interim Quality Manager for several of her early-stage start-up clients. Mary helped develop and teaches the AAMI 510(k)/De Novo and the Lead Auditor courses. In her free time, Mary enjoys camping and boating with her husband, baby son, and two dogs. At home, she can be found trying new recipes in the kitchen or tending to her chickens and garden. 

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