About

With over 20 years of experience in the MedTech industry, Niki Spaniel is a seasoned expert in regulatory, quality, and clinical areas, specializing in U.S. FDA and EU medical device regulations. Niki’s career began with roles in quality and regulatory at start-ups and leading MedTech manufacturers, where she developed a deep understanding of compliance and innovation. Her experience also includes work at a Contract Manufacturing Organization (CMO), providing her with a comprehensive perspective on the challenges of bringing medical devices to market.

For the past 14+ years, Niki has dedicated her expertise to consulting, offering strategic guidance and hands-on support to more than 50 manufacturers. Her services cover regulatory strategies, submission support, clinical study design and support, quality systems, and post-market clinical follow-up, ensuring that clients not only meet regulatory requirements but that their products excel at treating patients effectively.. As a Regulatory Affairs Certified (RAC) professional, Niki is committed to staying current with the evolving regulatory landscape while delivering business-balanced solutions to her clients.

Niki resides in Florida with her husband, two beautiful daughters, and golden doodles. They enjoy spending time at the beach, where they can unwind and admire the breathtaking Florida sunsets.