Team Elexes 
Elexes Team 
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…
Join the Growing Team of Elexes
At Elexes, we are more than just a medical device regulatory consultancy, we are a team of passionate experts dedicated to advancing the medical device industry.
Our collaborative approace and spirit is what makes us successful while tackling the complex regulatory frameworks across the globe.
Our global team of Life Sciences specialists includes leaders in regulatory affairs, compliance, and clinical functions. We don’t just follow the standards—we are at the forefront of them! Our mission goes beyond service delivery; we are driven by a passion to help transform the medical device industry and ensure that products meet the highest safety and efficacy standards.
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.
What are we Looking for?
We are looking for talented individuals to join our team in the following areas:
⦿ Regulatory Affairs Consulting
⦿ Medical Device Compliance
⦿ FDA and EMA Submissions
⦿ Quality Management Systems (QMS)
⦿ Clinical Trials and Post-Market Surveillance
⦿ Subject Matter Experts (SMEs) in the Medical Device Regulatory Domai
At Elexes, you’ll do more than contribute to regulatory solutions—you’ll lead them.
If you decide to be a part of our extensive team, you will get the opportunity to build customized regulatory strategies, optimize regulatory processes and help medical device manufacturers and companies market their product globally.
So, why wait?
Join us and be a part of growing team of regulatory experts dertermined to make a difference in regulatory industry.
Build a career as one of the expert regulatory consultants across the globe under the guidance of expert team of professionals.
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 -
Looking For Regulatory Assistance?
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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.
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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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