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.

Regulatory

Navigating 510k & DeNovo Requirements (Nov24)

Nov 12 to Nov 15, 2024

Regulatory

Navigating 510k & DeNovo Requirements (Mar25)

Mar 10 to Mar 13, 2025

Regulatory

Practical Post Market Survellance for Medical Devices (Mar 2025)

Mar 17 to Mar 20, 2025

Regulatory

Lead Auditor for Management Systems & Process: Principles & Practices (April25)

Apr 22 to Apr 23, 2025

Regulatory

Practical Post Market Surveillance for Medical Devices (Sept 2025)

Sep 22 to Sep 25, 2025

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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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

Practical Post Market Surveillance for Medical Devices

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Faculty

Pooja Kartik

As a seasoned Leader with over 23 years of experience and a Vice President of Quality & Regulatory, Pooja drives excellence in Medical Technologies, including digital health and combination products. Her expertise lies in building strong teams, coaching and mentoring teams to excel, negotiations, and alignments with stakeholders including regulatory bodies worldwide, global quality & regulatory strategy, regulatory compliance, risk management, software design quality and post-market surveillance.

With a hands-on approach, she has established quality systems based on FDA QSR (device and combination products), EU MDR/IVDR, EU MDD, ISO 13485 and MDSAP for class 1, class 2, and class 3 medical devices, strategized and lead FDA inspections, and global audits, lead teams conducting design quality activities, digital applications program portfolio management, product quality activities, CAPAs, recalls, management reviews, led remediation strategies and execution post FDA inspection/notifying body audits, and guided stakeholders through global regulatory and compliance.

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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