All available Prodct training courses
Preparing for Your First ISO 13485 Audit or FDA Inspection with Confidence and Humility
For small to mid-sized companies facing their first ISO 13485 audit or FDA investigation, the process can feel overwhelming. With so much at stake, it’s natural to worry about getting everything right.
Risk Management ISO 14971 Training
Creating a risk-minded culture in medtech is hard. Risk Management can be boring and confusing. We get it... we’ve struggled too.
Built from our own trials and triumphs, this course offers well-traversed pathways to implementing risk management in regulated organizations in a fun and interactive way.
Empathy-Driven Leadership: Empowering Teams in Startup
Empower your team through understanding: Cultivate empathy-driven leadership for startup success.
Navigating the fast-paced world of startups can be tough—juggling growth, tight deadlines, and a high-pressure environment. This course will guide you in using empathy-driven leadership to turn these challenges into opportunities for team cohesion and success.
Creation and Maintenance of Lean Quality Management Systems for Class I, 510(k) exempt Medical Device
Tackling FDA Quality System (QS) regulations can be confusing, especially for Class I 510(k) exempt medical devices. We know the challenges firsthand and have designed this course to make the process clearer and more engaging.
Requirements Management - Best Practices for Medical Device Companies
Skip the fine print at your peril—because in the world of medical devices, the devil’s not in the details, it is the details.
Step into the world of “Requirements Management,” where we unveil the crucial details that turn user needs into actionable design inputs, ensuring your product not only meets user expectations but is also fully testable.
GLP Training for Early-Stage Companies: Laying the Foundation for Scientific Integrity
Imagine doing groundbreaking work in the lab but not getting the credit because your processes couldn’t scale. Don’t let that happen. Your science deserves better.
Navigating the intricacies of Good Laboratory Practice (GLP) can be overwhelming especially as technology evolves rapidly in today’s digital landscape.
Risk-Ready: Mastering Essential Tools for Medical Device Success from Concept to Market
Start strong, finish stronger: Master the tools that safeguard your medical device from concept to market.
For early-stage medical device companies, effective risk management is critical from the very beginning of product development through to market launch and beyond.
Startup Hiring Mastery: From Strategy to Selection
Build the dream team that powers your startup's success.
Building the right team is the single most important step founders and the leadership team can take to ensure company success. We’ve been there, and know how that responsibility can feel overwhelming.
Turning Conflict into Opportunity: Conflict Management for Startups
Turn tension into triumph: Master conflict management to strengthen your startup team.
In the fast-paced world of small startups, conflict can be a daily challenge. With limited resources, overlapping roles, and high pressure to perform, tensions often arise. This course is designed to help you navigate and resolve these conflicts, turning them into opportunities for growth and team cohesion
Adaptive Leadership in Startups: Mastering Situational Leadership
Lead with agility: Apply situational leadership to thrive in a fast-paced startup environment.
In the unpredictable world of startups, leadership is not one-size-fits-all. As a startup founder or leader, you're constantly juggling shifting priorities, evolving roles, and a team that’s growing as fast as your business. This course is designed to help you master situational leadership—an adaptable approach that fits the ever-changing needs of a startup.
Navigating Labeling for Early Stage Medical Device Companies
Master Medical Device Labeling! In the intricate world of medical devices, effective labeling is more than just a regulatory checkbox—it’s your key to ensuring safety enhancing user experience and building trust in your brand. We know labeling can seem daunting and complex, but it doesn’t have to be.
Navigating Investor Diligence in Medtech
Transform your medtech vision into investor-ready reality. Preparing for investor diligence can be challenging, especially when your medtech startup’s future is at stake. Whether facing pre-seed, seed, angel, venture capital, or strategic diligence, this course equips you to prepare your team, plans, and technology to withstand rigorous investor scrutiny.
Verification and Validation
Feeling lost or intimidated by the prospect of Verification and Validation in a regulated industry? It can scary, but it doesn’t have to be.
Introduction to QMSR
Ready or not, QMSR is coming! - The FDA's new QMSR won't wait for you to catch up. Scared? Feeling Lost? That’s understandable. We are here to help ensure your Quality Management System is ready.
In February 2024, the FDA introduced new Quality Management System Regulations (QMSR) to incorporate ISO 13485:2016 by reference, creating significant changes in the compliance landscape by February 2026. If your QMS is primarily structured around the previous FDA regulations, or if you're a startup beginning to build your quality system, planning a smooth transition is crucial.