Team Elexes 
Elexes Team 
What Are Companion Diagnostics?
Companion Diagnostics (CDx) are specialized diagnostic tools that work in tandem with specific therapeutic drugs to identify patients who are most likely to benefit from a particular treatment. These devices are crucial for personalizing medicine based on patient-specific characteristics like genetics or biomarkers.
The development of these products usually calls for a collaborative approach between medical device manufacturers and drug manufacturers.
At Elexes, we understand the unique regulatory landscape for Companion Diagnostics. Regulated under both the FDA and IVDR frameworks, these diagnostics require thorough analytical and clinical validation. Our expertise helps you navigate these regulations, ensuring your product is safe, effective, and ready for market.
How We Help with Key
Design Documents for Companion Diagnostics?
We guide you through the preparation and submission of critical design documents required for Companion Diagnostics, ensuring all aspects of regulatory compliance are covered:
Here's how we can assist:
Intended Use Statement
We help define the precise relationship between your diagnostic device and its corresponding therapeutic counterpart, ensuring clarity around the conditions for its use.
Clinical Validation Report
We assist in linking test performance to patient outcomes, helping you substantiate claims for safety and effectiveness.
Usability Testing
We help ensure your device is user-friendly and can be safely and effectively used by the intended user population.
Software Design Documentation (if applicable)
If your device involves software, we guide you through the necessary validation processes, including cybersecurity and interoperability standards.
Analytical Validation Report
Our team supports you in generating the necessary data to demonstrate assay performance, including sensitivity, specificity, accuracy, reproducibility, and robustness.
Risk Management File
We ensure that your risk management documentation meets ISO 14971 standards, including risk analysis, evaluation, and mitigation strategies tailored to your device.
Labeling Documentation
We support the creation of comprehensive Instructions for Use (IFU) detailing test execution, result interpretation, and limitations.
Regulatory Submission Dossier
Our experts prepare your FDA Premarket Approval (PMA) submission or EU CE marking under IVDR, ensuring all conformity assessments are in place for a smooth approval process.
How We Help with Key Considerations for Companion Diagnostics?
We focus on ensuring your Companion Diagnostic meets all regulatory requirements while optimizing performance and safety:
Testing Requirements
We help you meet stringent testing standards, ensuring the diagnostic provides reliable and reproducible results. From analytical validation to clinical validation and evidence supporting the intended use, we cover all bases.
Performance Evaluation
We support your performance evaluations by helping demonstrate scientific validity, clinical performance, and how your device facilitates clinical decision-making.
Risk Management
We have a tested risk management approach that is designed through years of analysis and mitigation strtegies that we have used.
Premarket Approval (PMA)
Navigating the approval process can be complex. We ensure that your Companion Diagnostic meets the FDA’s PMA requirements or the EU’s IVDR conformity assessments, giving you the best chance for approval.
How We Help with Post-Market Requirements for Companion Diagnostics?
After your Companion Diagnostic is on the market, we continue to support you with comprehensive post-market monitoring to ensure ongoing safety and compliance:
Post-Market Surveillance (PMS) Plan
We help define the processes for monitoring device performance, patient outcomes, and adverse events, ensuring your device continues to meet safety standards post-launch.
Post-Market Performance Follow-Up (PMPF) Plan
As required under the EU IVDR, we assist in collecting real-world performance data and ensure your device’s effectiveness is continuously validated.
Adverse Event Reports
We help you submit a report in case of any adverse event. This ensures timely and accurate documentation of any issues that could impact patient safety.
Trend Analysis Reports
We assist in statistical evaluations of recurring issues, such as false positives or negatives, to identify and address any emerging problems early.
Regulatory Vigilance Reports
We help you prepare and submit any necessary reports to the EU Competent Authorities or FDA if significant risks arise post-market.
Software Update and Patch Documentation (if applicable)
For software-based devices, we ensure proper documentation of updates, patches, and validation to maintain compliance and optimal performance.
Clinical Evidence Updates
Our experts help you in gathering accurate clinical data, ensuring your diagnostic remains accurate and relevant in the context of new therapies and treatments.
Our Expertise
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.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Our Services
Our Compliance Assessment Process
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.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
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.
Local Regulatory Certification
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.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Our New Product Approval Service Corner
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 -
Associated Regulatory Authorities.
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Clients Testimonials
Amazing Feedback Say About Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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