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Do you need help with regulatory workload management? Elexes, among the regulatory outsourcing companies, offers end-to-end solutions tailored to medical device, biotech, and IVD firms. From getting products to new markets to supporting compliance, our regulatory consultants ensure that deadlines are kept and the quality is high.
Our global reach and scalable support have helped startups and Fortune 500s reduce overhead, speed up approvals, and minimize audit risks.
Let us handle the complexity so you can focus on innovation.
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Unlike traditional regulatory outsourcing firms, Elexes offers flexibility, transparency, and domain-specific expertise across global markets including the U.S. FDA, EU MDR, TGA, and Health Canada.
Our outsourcing support includes:
⦿ Regulatory strategy development and gap analysis
⦿ Global dossier and technical documentation preparation
⦿ Ongoing regulatory maintenance (post-market surveillance, labeling updates, etc.)
⦿ Health authority submissions (510(k), CE Mark, De Novo, PMA, TGA submissions, etc.)
⦿ Audit preparedness and QMS support
⦿ Design History File (DHF) support
With real-time project updates, scalable resources, and expert-backed deliverables, we empower your team with the confidence to move faster and smarter.
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At Elexes, we do not just finish the job or task until the client wants to. We become a part of the team. Temporary support during a peak load or long-term outsourcing is whatever one may want, and our experienced professionals integrate flawlessly with the operations.
Regulatory compliance is carried through to all regulatory milestones:
⦿ Clinical evaluation reports (CER)
⦿ Regulatory strategy and risk management plans
⦿ ISO 13485 and MDSAP compliance documentation
⦿ FDA Pre-submission and 510(k) filings
⦿ Software documentation and SaMD validation
Download our Regulatory Outsourcing Readiness Checklist
Everything you need to evaluate your organization’s readiness to outsource regulatory compliance tasks successfully.
Working with the right medical device regulatory outsourcing company can mean the difference between delay and delivery. These infographics illustrate key decision pathways and benefits of outsourcing to a qualified partner like Elexes.
Startups, small-medium enterprises, and large manufacturers are often benefited from regulatory outsourcing. When internal resources all become insufficient, outsourcing to experts like Elexes ensures efficiency.
Yes. We follow strict confidentiality protocols and sign NDAs to protect sensitive data.
Consulting offers guidance, while outsourcing includes hands-on execution and deliverables. Elexes offers both based on client needs.
Sure. From submission prep to post-market surveillance outsourcing, you decide on the actual scope.
Start with a no-obligation call. We’ll assess your needs and propose a tailored plan.
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.
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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