MEDICAL DEVICE REGULATORY CONSULTING
Specializing in pre-market strategy, development, and commercialization
From early-stage companies to established Fortune 500 industry leaders, Nex-RA offers a wide range of Regulatory consulting services with the necessary tools and expertise to help innovate and grow your medical device business. We partner with our clients, large and small, focusing on their needs while leveraging our extensive industry experience. Nex-RA will help you develop effective market pathway strategies, and most importantly, implement them in an efficient and compliant way. Contact us today to learn more.
WHO WE ARE
Experience meets Innovation
Each of Nex-RA’s associates has at least 10 years of direct experience in the medical device industry, and at minimum, graduate degrees in Biomedical Engineering, Mechanical Engineering, Regulatory Science, and other relevant technical disciplines. Nex-RA associates have held senior specialist and leadership positions in Regulatory Affairs, Quality Engineering, R&D, Operations, Manufacturing Engineering and Business Development with startup, mid-size, as well as Fortune 500 companies. In today's climate of rampant outsourcing, you can rest easy knowing all of Nex-RA's associates are fully trained and based in the US.
Nex-RA's US Regulatory Affairs experts each have obtained multiple 510(k) clearances for a wide variety of devices including orthopedic implants, sports medicine, spine, minimally-invasive surgery, surgical visualization, patient monitoring, in-vitro diagnostics, and neurology. Special emphasis is placed on Digital Health medical devices containing software and programmable systems, including Clinical Decision Support, AI, machine learning, and predictive analytics.
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The technical experts at Nex-RA re well-versed and comfortable working directly in the development and testing of new medical devices, alongside our clients’ R&D teams. The EU and International group has created Technical Files, Design Dossiers and have executed numerous product registrations in Europe, Japan, China, South Korea, Russia, Mexico, Canada, Singapore, Brazil, Australia, the Middle East, and other major markets.
All Nex-RA associates have significant expertise in supporting and running Notified Body, FDA surveillance and directed audits, as well as conducting ISO 13485 quality systems audits for suppliers and internal audits for clients. Nex-RA actively engages with the top industry organizations such as AdvaMed, MDMA, AAMI, RAPS, TOPRA, ASQ, EDUQUEST and local groups throughout the major US MedTech hotbeds including the SF Bay Area, Southern California, New Jersey, North Carolina, Chicago and Minnesota. Additionally, Nex-RA has a global reach with affiliates worldwide, assisting US firms with obtaining international market clearances as well as aiding foreign firms in obtaining US FDA clearance and/or approval.
NEX-RA SERVICES
Discover Our Expertise
PRE-MARKET STRATEGY ASSESSMENTS
Clearing the Way
At Nex-RA, we support our Digital Health and other cutting-edge clients with device classification, predicate searches, as well as market pathway and reimbursement strategy development. Our associates are uniquely qualified in the areas of Design Controls and medical device software development, and are ready to assist with your next innovative design effort. While proper planning is critical, implementation and execution is represents the bulk of the challenge facing medical device manufacturers in today's ever-changing regulatory landscape. Nex-RA is ready to turn your design concept into a reality. The well-known industry maxim of "fail early, and fail often" guides us in ensuring clients are always provided realistic timelines and an accurate understanding of the feasibility of their new device or design modification.
US FDA AND INTERNATIONAL REGULATORY AFFAIRS
Global Reach with a Personal Touch
With years of experience, our staff has the capabilities and expertise to take your business to the next level. At Nex-RA, our core competencies include US (Class 2, Class 3), EU (Class IIa, Class IIb, Class III), and ROW submissions and product registration activities. Whether it is a 510(k) premarket notification, or CE marking, we steadfastly support our clients from around the world in obtaining the correct level of market clearance for their devices in the US and abroad.
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If you are a manufacturer located in Europe or Asia, we are ready to assist you with commercializing your medical device in the crucial US medical device market.
QUALITY SYSTEMS AND GOOD MANUFACTURING PRACTICES COMPLIANCE
Continuous Improvement
Ongoing compliance with ISO 13485 and FDA cGMPs does not have to be a burdensome challenge. When implemented correctly, we find our clients are thrilled not only because they are successfully passing audits, but they are also seeing significantly increased speed to market and streamlined design and manufacturing processes. At Nex-RA, we look forward to leveraging our team's unique blend of RA, R&D, Operations, Quality Engineering, Manufacturing and BD expertise to accelerate your product development timelines while delivering a compliance record beyond reproach.
