As the founder of Lodestone Engineering, my name is Gino Albertini. I've spent my career immersed in quality and regulatory affairs, and I started this company to help others successfully navigate the very same challenges I know so well. When you work with Lodestone, you're working directly with me and my commitment to your success.

My journey to this point began at the University of Miami, where I earned a Bachelor's in Biomedical Engineering followed by a Master's in Engineering Management. With a strong foundation from my Six Sigma Black Belt certification, I’ve cultivated a tremendous expertise in project management and process optimization. I bring this unique blend of engineering knowledge, strategic oversight, and a disciplined approach to quality to every client, ensuring that your regulatory path is as clear and efficient as possible.

Lodestone Engineering was founded on a simple yet powerful idea: to be the trusted guide for companies navigating the complex world of medical device and tissue banking regulations. We understand that compliance is more than just a requirement—it's a critical pathway to success, and we help you turn intricate regulatory challenges into strategic opportunities for growth.

We've built our foundation on providing expert quality and regulatory consulting. Our deep understanding of FDA regulations—including the key principles of 21 CFR Part 820—along with international standards like ISO 13485 and ISO 14971, ensures you have a reliable compass to guide your journey to market success.

From building a Quality Management System from the ground up, to conducting internal audits, managing post-market surveillance, and ensuring process validation, we offer a comprehensive range of solutions. Our services are designed to adapt to your company's unique needs, helping you achieve and maintain compliance while driving innovation.

While Lodestone Engineering is currently headed by a single discipline, our long-term vision is driven by our commitment to our clients. We plan to evolve into a multi-disciplinary firm where a diverse team of experts will collaborate to provide comprehensive support for every critical aspect of your business. This growth is a direct reflection of our dedication to being a long-term partner, ensuring that as your company's needs expand into new technological and operational areas, we have the expertise to guide you at every step.