At Omnee Strategic Solutions, we specialize in regulatory affairs and quality compliance consulting for the medical device industry. With a clear focus on strategy, efficiency, and long-term success, we partner with medical device companies to help them navigate the complex and constantly evolving regulatory landscape with clarity and confidence.

Our expertise spans the full product lifecycle—from early-stage regulatory strategy and global submission planning to post-market compliance and quality system optimization. Whether you are preparing for your first 510(k) or PMA submission, responding to regulatory feedback, or scaling your quality management system to meet ISO 13485 or FDA 21 CFR 820 requirements, Omnee Strategic Solutions, delivers customized, actionable solutions tailored to your specific goals.

What sets us apart is our deep industry knowledge, practical approach, and commitment to excellence. We don’t just provide guidance—we become an extension of your team. Our collaborative style ensures that regulatory and quality activities are seamlessly integrated into your operations, enabling faster approvals, smoother audits, and stronger compliance outcomes.

From startups developing their first device to established manufacturers expanding globally, we are dedicated to supporting innovative companies at every stage of growth. At Omnee, we believe that regulatory compliance is not a barrier—it’s a strategic advantage.