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Navigating the complexities of IVD certification requires more than just technical knowledge. It demands deep regulatory insight, a tailored strategy, and precise execution. At Elexes, we simplify your path to IVD certification compliance with end-to-end support, whether you're seeking EU IVDR certification, FDA clearance, or global market access.
Our regulatory experts collaborate closely with your team to ensure full compliance, reduce approval timelines, and ensure faster product launches.
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Elexes supports IVD manufacturers in achieving certification across multiple regions. Whether you're preparing a Technical File under IVDR, seeking FDA 510(k) clearance, or complying with Health Canada and TGA requirements, we’ve got you covered.
We will consider your device classification, intended use, risk profile, and application in the regulatory domain. From the perspective of all the above, we will provide you with a step-by-step certification roadmap that aligns with your business goals.
Explore our specialized services for:
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Your IVD device's success depends on documentation quality. We help you build a solid foundation with:
⦿ Technical Files or Design Dossiers per IVDR Annexes
⦿ Risk Management per ISO 14971
⦿ Performance Evaluation Reports (PER)
⦿ Labeling and IFU reviews
⦿ Software and cybersecurity documentation (if applicable)
Our team ensures that all documents are audit-ready and aligned with the expectations of the Notified Body or Regulatory Authority.
Elexes is more than a consulting firm; we're your long-term compliance partner. With years of hands-on experience in regulatory strategy, quality systems, and product submissions, we help IVD companies accelerate approvals and avoid costly delays.
Understanding the IVD certification journey can feel overwhelming. Our visual tools simplify this process with clarity and direction.
We make global IVD certification smoother, faster, and fully compliant. Start your IVD certification process today.
IVD certification is the regulatory approval process that confirms an in vitro diagnostic device meets market-specific requirements.
IVDR certification typically takes 6–12 months, depending on the device classification and readiness of documentation.
Yes, except for Class A devices that are not sterile, IVDR requires review by a Notified Body for certification.
Yes, Elexes offers full support for both FDA 510(k) submissions and EU IVDR certification processes.
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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