Services
Ready, Set, Compliance!
Are you ready to redefine excellence in the medical device industry? I bring to you a proven track record and a passion for crafting robust Quality Management Systems (QMS) that not only meet but exceed ISO 13485 standards. I can support you on all regulatory submissions including FDA, EU MDR, ANVISA, JPAL, TGA, MD SAP and COFEPRIS. Let's embark on a transformative journey together!
Start your manufacturing in Mexico
If you are looking to start up or set up new manufacturing or manufacturing transfer to Mexico, we are your solution.
We specialize in medical devices, electronics, med-tech, molding, extrusion, automation and manual assemblies.; this includes all permits, manufacturing, certification, staffing, purchasing, location, basic everything.
Reach out and we will get you on your way to manufacturing in Mexico.
Global Compliance
Navigating the complexities of ISO 13485 on a global scale is my forte. Whether it's Europe, the USA, LATAM, or Asia, I understand the nuances of international regulatory landscapes, ensuring your QMS is globally recognized.
Training
The medical device industry is poised for groundbreaking advancements. Now is the opportune moment to fortify your organization with a QMS that not only ensures compliance but sets the stage for a future of unparalleled success.
Training and Certification is the key to success in any business. We will prepare your team on all areas of compliance.
Please reach out for a quick quote.
About Us
Policy
Mission
Mission
Our company is committed to providing high-quality services that meet and exceed customer expectations and comply with all applicable regulatory requirements, including ISO 13485:2016. We are dedicated to continuous improvement and the prevention of nonconformities throughout our process.
Mission
Mission
Mission
Our mission is to provide expert guidance and support to medical device companies to ensure compliance with applicable regulatory requirements. We strive to enable our clients to achieve their business goals while maintaining the highest standards of quality and patient safety.
Vision
Mission
Vision
Our vision is to be the premier subject matter expert in medical device compliance, providing unparalleled expertise, guidance, and support to clients worldwide. We aim to be the go-to resource for companies seeking to navigate the complex and ever-changing landscape of medical device regulations, and to help them achieve their goals of improving patient outcomes and enhancing public health.