Episode description
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
🔦 Today, we're back with a BONUS Excellence Spotlight video featuring two case studies from Vice President of Technical, Jonathan Gimbel. Here's a link to Jon's original feature if you haven't seen it.
While these case studies will obviously demonstrate Jon's wealth of experience in action (even though he's shy about it!), we also hope they demonstrate the true depth of expertise at RQM+ and our dedication to helping clients through a multitude of challenges, including navigating the complex landscape of regulations and quality standards.
👷♂️ Case Study 1: From Ground Up to Success 👷♂️
Jon collaborated with a small company that had a groundbreaking wound healing device for negative pressure wound therapy. With a strong belief in their product but limited regulatory understanding, Jon and the RQM+ team stepped in. They meticulously audited the company, identified gaps, and much more. From developing a comprehensive quality system to guiding them through FDA audits and even drafting the 510(k) submission, this partnership yielded a full-service solution.
🏥 Case Study 2: Transforming Adversity into Collaboration 🏥
Amid recalls and warning letters, RQM+ played a pivotal role in restoring harmony at a company facing challenges with understanding FDA requirements. By assisting in recall resolutions, obtaining critical 510(k) submissions, and fostering a collaborative relationship with the FDA, Jon and the team transformed an adversarial dynamic into a collaborative one.
Again, we hope these case studies demonstrate RQM+'s commitment to supporting clients through every twist and turn! At RQM+, we're thankful for Jon's deep knowledge and leadership.
--
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.