MDD Five-Part QMS Webinar Series

In today’s medical device landscape, quality leaders are expected to be cross-functional navigators, influencing design, risk, supplier, and system-level decisions.

This five-part webinar series brings a sharp focus to the QMS elements that drive real-world performance and patient safety. Each session features seasoned professionals sharing case studies, regulatory insights, and practical tools to improve your systems and strategy.

📅 Webinar Schedule at a Glance

The webinar series is priced at $10 per session for ASQ members and $20 per session for non-members. Participants who register for all five sessions by July 16 will receive a discounted rate equivalent to the cost of four sessions.

Note: Each session qualifies for 0.1 RU toward ASQ recertification.

🔍 Session Details & Speaker Highlights

📅 July 16 – What Went Wrong (and What You Can Do About It)

Speaker: Jerry Valenti, P.E.

Synopsis: Explore critical failures in both automotive and medical device systems and the design quality lessons they offer. Jerry will walk through the Toyota unintended acceleration case and the FDA's Infusion Pump Initiative, highlighting how design, software, and risk management gaps can lead to serious consequences. Attendees will gain practical insights to strengthen software integrity and risk controls in their organizations.

About Jerry: Jerry is a licensed electrical engineer with deep experience in design controls, software QA, and risk management for Class II devices. He led an MDR submission for a startup and holds ISTQB certification. Jerry is active in ASQ and regulatory circles in Orange County.

LinkedIn: Jerry Valenti

📅 August 20 – Risk… Don’t Let This 4-Letter Word Scare You

Speaker: Mark Swanson

Synopsis: In this session, we’ll hear from an ISO working group expert about the use of risk management in quality systems and product (or service) realization. The discussion will cover the definition and application of risk across ISO 14971 and ISO 13485 — the cornerstones for medical devices — as well as touch on ISO 31000 and risk concepts in ISO 9001. We’ll also explore what’s coming in the next revisions of these standards. Bring your risk challenges — we’ll help you move forward.

About Mark: Mark Swanson (MBA, CMQ/OE, CQE, CMDA) is co-founder of Quality and Regulatory Expert Partners. With over 25 years in medtech, he helps companies align ISO and FDA frameworks. Mark leads ASQE’s CMDA exam development and contributes to ISO TC210 and TC176 working groups.

LinkedIn: Mark Swanson

📅 September 17 – Design Controls: Harnessing Agile Processes

Speaker: Kamala K Nanjundeshaiah

Synopsis: The adoption of Agile methods in medical device development offers both opportunity and complexity. This session explores how Agile can be effectively applied in software development lifecycles while meeting regulatory requirements. Kamala will share strategies for aligning Agile practices with ISO 13485, ISO 14971, and IEC 62304, helping teams embrace agility without compromising compliance.

About Kamala: Kamala leads software design quality and compliance for AI-powered devices. She is Editor-in-Chief for the ASQ Medical Device Division, a frequent conference speaker, and a passionate STEM advocate. Kamala holds ASQ CQE and CQA certifications.

LinkedIn: Kamala KN

📅 October 15 – Supplier Quality Risk Management Application

Speaker: James “Gunny” Shore

Synopsis: Risk-based decision-making is a powerful tool in supplier quality management. In this session, James will outline practical approaches for applying risk during supplier selection, auditing, and ongoing monitoring, enabling teams to maximize quality while optimizing resources and reducing inefficiency.

About James: James Shore, Chief Quality Officer at Quality Lean Solutions, brings over 30 years of experience in the medical technology (medtech) and aerospace industries. He co-authored Proactive Supplier Quality Management and holds multiple ASQ and AWS certifications. A retired U.S. Marine Corps Gunnery Sergeant, James is known for delivering practical and scalable QMS solutions.

LinkedIn: James Shore

📅 November 13 – Process Validation: A Practical Approach

Speaker: Karen Brozowski

Synopsis: Karen will explore real-world lessons from validation projects — what works, what fails, and what regulators are watching closely. 

About Karen: Karen Brozowski brings 30+ years of experience in QA/RA leadership roles, including VP of Quality for a global device manufacturer. Her portfolio spans urology, cardiovascular, surgical, and IVD devices. She is an ASQ CMDA, Certified Supplier Quality Professional, and a RAPS-certified RA professional. Karen serves on the ASQ MDD Board and previously led the WCQI program.

LinkedIn: Karen Brozowski

✅ Why Attend?

✔️ Gain actionable insights from seasoned quality experts
✔️ Align your QMS with current FDA and ISO expectations
✔️ Strengthen your team’s approach to design, risk, supplier, and validation
✔️ Join a professional community of peers and thought leaders

🚨 Get Involved with the ASQ Medical Device Division! 🚨

The Medical Device Division (MDD) is actively seeking volunteers to support various committees and help fill several open leadership positions.

This is a fantastic opportunity to:
✅ Enhance your leadership skills
✅ Gain valuable project management experience
✅ Network with industry professionals and experts

Interested? Contact Santosh Suggu at: suggu.santosh@gmail.com or Bob Shanks at: – bobshanks@hotmail.com

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