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
Regulatory Writing for Medical Devices (August 2025)
Aug 12 to Aug 14, 2025
Regulatory
Practical Post Market Surveillance for Medical Devices (Sept 2025)
Sep 22 to Sep 25, 2025
Featured Courses
Regulatory
Lead Auditor for Management Systems & Processes
Regulatory
Navigating 510k & De Novo Requirements
Regulatory
Practical Post Market Surveillance for Medical Devices
Regulatory
Regulatory Writing for Medical Devices
Regulatory
Valid Statistical Techniques for Regulatory Compliance
Why do people fear statistics?
- Is the subject too complex and difficult to understand?
- Do they get overwhelmed by the terminology in regulations, standards, and guidance documents?
- Are statistical software tools a maze of terms and menu paths?
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
Jack Ward
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.
