From Concept to Clearance—We Guide the Way.
We help MedTech companies navigate complex regulatory landscapes—EU MDR, US FDA, and beyond—with speed & precision.
At Omnee Strategic Solutions, we specialize in guiding medical device manufacturers through the complex landscape of global regulatory compliance and quality system integration. Our end-to-end support spans the full product lifecycle—from device classification and regulatory strategy to technical documentation development, conformity assessment, and global regulatory submissions, including CE marking under EU MDR, FDA 510(k)/PMA pathways, and ROW market approvals. With proven expertise across all device risk classes (Class I–III), we embed regulatory intelligence, ISO 13485-compliant quality systems, and proactive risk management into your development process. In an increasingly scrutinized MedTech environment, regulatory alignment and quality assurance are not just compliance requirements—they are strategic imperatives. We partner with you to ensure readiness, resilience, and sustained market success.
Regulatory & Quality Services
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Regulatory Strategy Development
Bringing a medical device to market requires more than just innovation—it demands a clear, compliant, and market-tailored regulatory strategy. At Omnee Strategic Solutions, we specialize in helping medtech companies develop and execute regulatory strategies that streamline approvals, reduce risk, and support business goals across global markets.
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Regulatory Submission Development
Your innovation deserves a smooth, successful path to market—and that begins with a strong regulatory submission. At Omnee Strategic Solutions, we guide medtech companies through the complex process of preparing and submitting regulatory dossiers that meet the highest global standards.
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Labelling and Ad-Promo
What you say about your device is just as important as what it does. At Omnee Strategic Solutions, we ensure that your labelling, instructions, and promotional materials are not only compelling—but fully compliant with global regulatory standards.
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Post - Market Compliance
Achieving market approval is just the beginning—maintaining it is where the real work begins. At Omnee Strategic Solutions, we support medtech companies in meeting ongoing post-market regulatory obligations, ensuring continued safety, performance, and global compliance.
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Quality Management Systems (QMS) Development & Implementation
A strong QMS is the backbone of a compliant, efficient, and market-ready medical device organization. At Omnee Strategic Solutions, we help medtech innovators build and maintain robust, audit-ready quality management systems that support global regulatory compliance and long-term operational success.
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Software as a Medical Device (SaMD) & Digital Health Compliance
Innovating in digital health is exciting—but navigating the regulatory landscape is complex. At Omnee Strategic Solutions, we help SaMD and digital health companies turn innovative code into compliant, market-ready products across global markets.
From mobile health apps and AI/ML-based tools to cloud-connected diagnostics, we provide expert regulatory support tailored to the unique challenges of software-driven solutions.
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Risk Management & ISO 14971 Compliance
Risk management isn’t a checklist—it’s a mindset woven into every stage of your product lifecycle. At Omnee Strategic Solutions, we help medical device and digital health companies implement robust, ISO 14971-compliant risk management systems that ensure patient safety, regulatory compliance, and product confidence.
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Regulatory Intelligence
In today’s fast-paced regulatory landscape, staying ahead of changes is key to maintaining compliance and ensuring market success. At Omnee Strategic Solutions, we provide cutting-edge Regulatory Intelligence to help medtech companies navigate evolving global regulations and anticipate changes that may impact your products, operations, and market access.
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Regulatory Compliance & Quality Systems Audit Support
Audits and inspections can make or break your ability to enter—or stay in—global markets. At Omnee Strategic Solutions, we partner with medical device and digital health companies to ensure your quality systems and regulatory documentation stand up to scrutiny from regulators, notified bodies, and certifying agencies worldwide.
From FDA inspections and EU MDR audits to CDSCO reviews and ISO 13485 certifications, we help you walk in with confidence—and walk out with success.
Learn What Our Client Say About Us
Senior Manager, Regulatory Affairs – Large Medical Device Company
“As a client of Omnee Strategic Solutions, I highly recommend their services to help navigate medical device compliance. This firm is knowledgable on US FDA and EU MDR requirements, and has driven excellent results through many regulatory challenges. Regulatory professionals tend to seek resources that can demonstrate current involvement with many regional registration laws; especially when regions are constantly revising regulations. Medical device knowledge of quality system requirements is also very, important. I choose to partner with a group that possesses these strengths. Omnee Strategic Solutions is just that organization. They drives results and have helped me successfully cross many finish lines!”
Chief Executive Officer – Medical Device Start-up
“Navigating my way through the FDA application maze is an insurmountable task, something I not only had no idea as to where to begin or frankly had time for. Omnee Strategic Solutions, was able to navigate through this complicated process with ease and completed my task to get me up and running in quick order. I could have never done it without them!”
Vice President R&D – Midsize Medical Device Company
“Partnering with Omnee Strategic Solutions has been instrumental in our journey towards regulatory compliance and achieving excellence in quality assurance. Their team’s in-depth knowledge and proactive strategies have provided us with invaluable support in navigating complex regulatory landscapes. Thanks to their strategic guidance and meticulous attention to detail, we’ve accelerated product approvals and maintained strict adherence to industry standards. We highly recommend Omnee Strategic Solutions for their professionalism, expertise, and steadfast dedication to our success.”
Chief Executive Officer – Medical Device Start-up
“Working with Omnee Strategic Solutions has been a pleasure. Finding a regulatory professional that is both knowledgeable and business savy is rare. Omnee Strategic Solutions understands how to complete the task at hand in an efficient manner while ensuring that the regulatory requirements are completely met. I have previously worked with over a dozen FDA consultants and none had the regulatory knowledge combined and business acumen that Omnee Strategic Solutions possesses. Under Omnee Strategic Solutions direction and guidance, We received FDA 510(k) clearance in 3 months and 1 day, which is a remarkable result, while keeping the cost reasonable. We are now working with Omnee Strategic Solutions on further indications and our in-house quality system. Omnee Strategic Solutions offers complete supervision of the FDA process in a cost effective and professional manner, and we could not be more pleased with their services”
Chief Technology Officer – Midsize Medical Device Company
“Working with Omnee Strategic Solutions has been fitting for our company, the young OEM spine device manufacturer. Their expertise in Regulatory Affairs is unparalleled which they drive from many big medical device company experience they have, essentially eliminating the need for our in-house RA department. With Omnee Strategic Solutions guidance, we successfully navigated four FDA 510(k) submissions in the past two years, even challenging the FDA’s perspective and steering them to see through the lens of product developers. Their ability to think with us, and articulate complex product details and regulatory insights into successful submissions has been nothing but pleasant and invaluable.”
Contact Us Today
Fast track your innovative medical device to market with proven expertise in navigating global regulatory landscapes. We specialize in regulatory pathways and compliance for all classes of medical device, ensuring safe and effective market entry