Elexes is renowned for offering global regulatory consulting services for medical devices. With the experts we have from all across the globe, medical device companies do not have to look for any place else to market their products globally.
We have a successful track record for helping renowned medical device companies navigate through complex regulatory frameworks across the globe.
When it comes to regulatory requirements, every region has its own set of stringent regulations that medical device manufacturers have to follow, making it a daunting task. With Elexes at your side, you do not have to worry about any regulatory formalities. We have experts who have decades of experience helping medical device companies get global approval for their products.
Expert guidance on 510(k), PMA, and De Novo submissions.
Compliance with the latest EU Medical Device and In Vitro Diagnostic Regulations.
Assistance with UK MDR 2002 compliance and MHRA registrations.
Support for Medical Device Licenses (MDLs) and ISO 13485 certification.
Regulatory expertise for markets like Japan, China, India, and Australia.
At Elexes, we offer comprehensive support for regulatory and quality management compliance. From designing tailored regulatory pathways for your medical device to implementing robust Quality Management Systems (QMS) that meet ISO 13485 and US FDA 21 CFR Part 820 standards, we provide end-to-end solutions.
Beyond our expertise in US FDA and EU MDR/IVDR compliance, we assist with challenges faced by medical device companies globally, including:
⦿ QMS Audits
⦿ Risk Management
⦿ Literature Reviews
⦿ Regulatory Strategy Development
⦿ And much more.
Partner with Elexes to ensure your device meets international regulatory standards with confidence.a
At Elexes, we specialize in helping medical device and IVD manufacturers establish and maintain Quality Management Systems (QMS) that comply with global standards such as ISO 13485, US FDA Quality System Regulation (21 CFR Part 820), and other international quality regulations.
While ISO 13485 forms the foundation for QMS compliance, markets like the United States, Canada, Brazil, and Japan have unique additional requirements. Our team of experienced quality management consultants ensures your QMS not only meets current regulations but is also future-proofed for global market expansion.
Whether you’re building a new QMS or upgrading an existing one, Elexes offers the expertise to navigate complex requirements and ensure seamless compliance.
At Elexes, we offer expert support to help your medical device company achieve compliance through the Medical Device Single Audit Program (MDSAP). This program streamlines regulatory compliance by allowing a single audit to meet the requirements of multiple regulatory authorities, including the US FDA, Health Canada, Australian TGA, Brazil ANVISA, and Japan MHLW/PMDA. Our team of experienced auditors conducts in-depth assessments of your Quality Management System (QMS) to identify compliance gaps and provides actionable recommendations to strengthen your processes, ensuring seamless adherence to global regulatory standards.
Dealing with an FDA Warning Letter, FDA 483, or significant findings from an EU Notified Body can be overwhelming. A swift, thorough, and strategic response is essential. Our team of regulatory experts is ready to guide you through the process. We will conduct a prompt analysis of the issues raised, develop a comprehensive remediation plan, and assist in drafting clear, effective responses to the regulatory authorities.
Our services include:
⦿ Root cause analysis
⦿ Corrective and preventive action (CAPA) development
⦿ Implementation support to close compliance gaps
Additionally, we provide training and ongoing guidance to ensure your team fully understands regulatory expectations and sustains compliance in the future.
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.
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
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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