Team Elexes 
Elexes Team 
Clinical trial management support
It is vital that your medical device meets all regulatory requirements and we, at Elexes Medical Device consulting offer right resources to help you manage all the complex reviews needed for medical device clearance at the clinical trial stage.
Our team comprises of experienced medical device clinical research and regulatory experts who can help you at every stage of medical device manufacturer. Right from preparing early stage regulatory strategy to for preclinical interactions to commercial & post-marketing activities, we offer complete range of clinical trial management support.
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 expertise in clinical trial management support for medical devices
Our medical device clinical research and regulatory team of experts will help you create detailed usability files. Our services will include assisting you with -
- Required documentation
- Complete formative & summative evaluations
- Conduct risk/benefit analyses
- Ensure usability requirements are met across the entire product development lifecycle
- Generate, collect, analyze, and evaluate clinical data, preparing clinical evaluations
- Manage investigational review board submissions
- Prepare for and run medical device clinical trials
- Offer trainings as per the ISO 14155 & GCP requirements
- Create high-value templates for informed consent form, investigator’s brochure, case report form, and more…
So, if you are looking for a professional to assist you with clinical trial management, all you have to do is contact us.
Our Services
Market Feedback Analysis
We analyze customer feedback and market trends to identify potential product improvements…
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Regulatory Updates and Compliance
Our experts stay up-to-date with evolving cosmetic regulations and ensure your products…
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Post-Market Surveillance Reporting
Our team helps in preparing and submitting necessary post-market surveillance reports to…
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Product Quality Monitoring
We provide guidance on establishing quality control processes to monitor the consistency…
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Corrective and Preventive Actions (CAPA)
In case of any product-related issues or non-compliance, we help you plan…
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Customized Post-Market Surveillance Plans
We create tailored post-market surveillance plans to meet your specific product and…
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Product Recalls and Withdrawals
If necessary, we assist in planning and executing product recalls or withdrawals…
Read MoreOur 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.
Expertise
Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.
Customized Solutions
We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.
Why Choose Elexes?
Efficiency
We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.
Compliance Assurance
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
Confidentiality
We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.
Looking for someone who can assist you?
Contact us
Elexes Team
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.
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.
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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.
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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.
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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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