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Managing global regulatory requirements can be overwhelming, especially when your in-house resources are limited. That’s where Elexes steps in. Our regulatory outsourcing services are tailored for medical device, IVD, biotech, and SaMD companies that seek expert support without expanding their internal team.
From compiling FDA submissions to managing ISO and CE certification, we embed our regulatory specialists into your operations, just like your internal team, only faster and more experienced.
We help you meet timelines, reduce cost, and stay compliant across geographies.
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In-house regulatory teams can be expensive to scale, especially when your needs fluctuate across project stages. With regulatory outsourcing for medical devices, you gain access to experienced professionals only when needed, reducing overhead and increasing operational agility.
Elexes' outsourced regulatory affairs solutions allow you to focus on product development and commercialization, while we handle the complexities of international compliance.
We offer scalable, on-demand, and strategic support, whether you need help with a one-time submission or a long-term regulatory partner.
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Whether you're a startup preparing your first 510(k) or an established firm expanding into Europe under MDR, Elexes has your back. Our regulatory outsourcing services scale with your business needs. We support early-stage startups, mid-sized innovators, and large manufacturers alike.
We’ve supported:
⦿ 510(k), De Novo, and PMA submissions
⦿ ISO 13485 implementation
⦿ CE marking under MDR & IVDR
⦿ Post-market surveillance & vigilance
We tailor our support based on your stage, risk classification, and global expansion plans.
We go beyond consultation. We become your regulatory engine, delivering services tailored to your company size, region, and product class.
FDA and Global Submissions
We prepare and manage your regulatory submissions, 510(k), De Novo, PMA, Health Canada license applications, TGA registrations, and more. Our team ensures all documentation is audit-ready and aligns with region-specific expectations.
Quality System Support (ISO 13485, QMSR, MDSAP)
Our experts help implement, maintain, or remediate your Quality Management System. Whether you're preparing for an MDSAP audit or aligning with FDA’s QMSR, we ensure full compliance and documentation.
CE Marking & EU MDR/IVDR Compliance
From GSPR checklists to clinical evaluation reports (CERs), we help you meet CE marking requirements under EU MDR and IVDR. We also support Notified Body responses, vigilance reporting, and periodic safety updates.
Post-Market Surveillance & Vigilance
We take care of PMS plans, vigilance reporting, complaint handling, and trending analysis, so your product stays compliant long after market entry.
Embedded Regulatory Professionals
Need day-to-day regulatory support? We embed trained professionals into your operations, virtually or onsite, working closely with your R&D, clinical, and QA teams.
Regulatory outsourcing shouldn’t be complicated. Our frameworks bring structure, visibility, and speed to your compliance journey.
Regulatory outsourcing is the practice of hiring external regulatory experts to manage compliance, submissions, and quality documentation for medical devices and IVDs.
Startups, small businesses, or companies expanding to global markets benefit most from regulatory outsourcing due to cost-efficiency and speed.
Elexes provides on-demand regulatory professionals who manage submissions, quality systems, PMS, and global compliance tailored to your product and market.
Yes. It reduces fixed costs of hiring in-house teams while offering flexible, scalable, and specialized expertise as needed.
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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