Activate Your Practice Podcast Navigating Medical Device Regulations: A Vital Conversation with Markus Gee on Chiropractic Compliance
Unlock the secrets to ensuring your chiropractic practice stands on the solid ground of regulatory compliance. As I, Dr. Arlan Fuhr, sit down with Markus Gee, Axeon Corporation's sage Director of Medical Device Division, we pull back the curtain on the often-neglected realm of medical device regulations. Our enlightening conversation promises to arm you with the knowledge to discern the risks of counterfeit devices and the profound importance of using licensed, safe, and effective equipment. Venture with us as we dissect the intricacies of the FDA's 820 quality system regulations, ISO 13485 standard, and the game-changing MedSAP certification.
Amidst this regulatory deep-dive, we pause to celebrate a historic moment for chiropractic care—Activator Methods' landmark achievement of securing the first 510K approval from the FDA. This trailblazing success not only stands as a testament to quality and innovation but also serves as a clarion call to the importance of rigorous compliance and quality assurance in our field. With Markus Gee's expert guidance, we share insights from our recent BSI audit triumph and reflect on the unwavering dedication and investment required to supply top-tier, research-backed chiropractic tools. Be inspired to hold your practice to the highest standards, ensuring the certifications of your instruments are not just a matter of legality but of patient care excellence.