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Quality and regulatory function outsourcing can deliver greater efficiency and cut costs, in addition to providing expert insights without compromising on compliance. At Elexes, we offer quality outsourcing services specifically tailored for medical device and biotech companies. Our consultants act as a full extension of your team to ensure that, when working with them, quality isn't just maintained but enhanced, whether you're a startup or a worldwide manufacturer.
Our services align with FDA, ISO 13485, EU MDR, and global standards, keeping your QMS audit-ready at all times.
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Navigating global regulatory landscapes and maintaining consistent quality processes can overwhelm in-house teams. With Elexes, you get immediate access to industry professionals with expertise in:
⦿ Regulatory documentation and submissions
⦿ QMS setup, maintenance, and audits
⦿ Risk management aligned with ISO 14971
⦿ CAPA, internal audits, and SOP updates
From handling day-to-day quality operations to remediation or pre-audit preparation, our outsourcing model ensures full transparency, measurable outcomes, and data confidentiality.
⦿ QMS development & maintenance (FDA, ISO 13485, MDSAP)
⦿ Internal and supplier audits
⦿ SOP writing and revision
⦿ CAPA management and root cause analysis
⦿ Complaint handling and vigilance reporting
⦿ Documentation review and gap assessment
⦿ Supplier qualification and monitoring
⦿ Regulatory submission support (510(k), CE Marking, TGA, Health Canada)
⦿ DHF/DMR/Design review support
⦿ SaMD and software documentation compliance
We offer full-time, part-time, or project-based outsourcing models tailored to your internal bandwidth and project timelines. Our consultants integrate seamlessly with your teams across time zones.
Our experts come with hands-on experience in US FDA, EU MDR, Health Canada, TGA, and more. Whether it’s a submission deadline or an unannounced audit, we’re always prepared.
Don’t let legacy systems slow you down. From building your QMS from scratch to updating existing systems to meet ISO 13485 or MDSAP standards, we streamline quality operations.
All outsourcing is governed by NDAs and secure access systems. Your documentation, designs, and records remain confidential and version-controlled.
Based in the US and supporting clients worldwide, Elexes understands regional compliance nuances, whether launching in Australia, Canada, Europe, or Asia.
We simplify the outsourcing decision-making and execution process with transparency and measurable results.
Quality outsourcing services involve hiring external experts to manage quality assurance and regulatory compliance tasks for medical device companies.
Medical device, diagnostics, biotech, and digital health companies benefit most by gaining access to skilled professionals without increasing headcount.
We sign NDAs and use secure systems with role-based access. Your data and documentation are protected at every stage.
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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