PC: Canva
A plethora of regulations worldwide makes internal management highly time-consuming, thus slowing product launch, and draining resources. Elexes' outsourcing of regulatory affairs enables you to immediately tap into experienced regulatory professionals who work hand in hand with your team. Be it a new device launch or maintenance of market approvals, we take care of the regulatory compliance side without the overhead.
Our services scale with your growth, helping you meet FDA, EU MDR, Health Canada, TGA, and ISO standards across all device classes.
Let Elexes handle your regulatory burden, so you can focus on innovation.
Trusted by startups to Fortune 500s
PC: Canva
Outsourcing isn’t just about reducing cost, it’s about gaining specialized regulatory leadership, flexibility, and operational efficiency. With Elexes, you don’t just get consultants, you get a strategic partner who understands your product, market, and compliance obligations.
Our outsourced regulatory affairs services include:
⦿ Complete lifecycle support from R&D to post-market surveillance
⦿ On-demand access to regulatory professionals
⦿ Cost-effective solutions with no compromise on quality
⦿ Faster submissions with reduced error rates
We work with medical device, SaMD, and IVD companies to ensure every submission is accurate, audit-ready, and strategically aligned with your business goals.
PC: Canva
Whether you need part-time support or a full external RA department, Elexes offers regulatory affairs outsourcing solutions that adapt to your operational model. Our team works within your systems and SOPs, or we bring our own.
We're known for stepping in during critical stages:
⦿ Clinical trial prep
⦿ Pre-submissions (Q-sub, FDA Pre-Subs)
⦿ CE Marking & Technical Documentation
⦿ 510(k), PMA, and De Novo Submissions
⦿ Global market entry (TGA, Health Canada, EU MDR/IVDR)
No long-term contracts. No hidden costs. Just compliance that works.
Our clients choose us for different phases of their device development and post-market lifecycle. Here’s how Elexes helps:
We build global regulatory roadmaps, device classifications, and go-to-market timelines aligned with your business strategy.
From 510(k) and PMA to CE Marking and IVDR, we handle dossier preparation, formatting, gap analysis, and agency correspondence.
We monitor evolving regulations and ensure product labels, claims, and IFUs stay compliant globally.
We help create, maintain, or manage your ISO 13485-compliant QMS and ensure your technical documentation is audit-ready.
We support complaint handling, periodic safety updates, and MDR/IVDR vigilance reporting to meet global post-market requirements
Explore how Elexes simplifies compliance and improves time-to-market through strategic regulatory support.
Elexes makes medical device regulatory outsourcing simple, scalable, and strategic.
Regulatory affairs outsourcing involves partnering with external experts to manage compliance tasks, submissions, and audits instead of building in-house teams.
Startups, growing medical device companies, and large enterprises benefit by accessing expert support while reducing costs and improving timelines.
Yes, Elexes supports FDA (510k, PMA, Q-sub), EU MDR/IVDR, Health Canada, TGA, and other international regulatory submissions.
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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