Management responsibility is crucial to the success of a QMS but what is it? Whats covered by the topic of management responsibility and whos the responsible party? In todays episode, youll hear from Sara Adams, Lead Auditor, Quality Engineer, and no

Combination products are a difficult niche because they combine so many different elements. However, todays guest literally wrote the book on the topic, and shes joining the podcast to share her insights. In todays episode, Susan Neadle and I spoke on

What is lean documentation and how can you achieve it? Our guest on todays live podcast is an expert on quality management systems, audits, and most importantly for todays conversation, documentation. Steve Gompertz is a partner at QRX Partners and has

The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic Act has expanded the scope of the FDA beyond just "safety and

With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming more so due to increased risk measures, and its important to understand whats hap

What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs professionals and regulatory affairs attorneys? Those are just a

What makes a clinical investigation run smoothly? In todays conversation, youll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical investigations

What would you think about dealing with complaints all day? Todays guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide companies through the var

When bringing a medical device to the market, its important to be aware of the fatal 510(k) flaw. In todays episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) progra

Whats it like to become a Medical Device Guru? In todays episode, youll meet one of our newer Gurus, Brittani Smith, and find out more about her role and journey working through UDI implementati