Team Elexes 
FDA Medical Device Regulatory Consulting Services
Elexes is one of the trusted FDA consultants globally with a track record of helping medical device manufacturers get the best medical device regulatory affairs support. Be it any medical device, we help companies get the best support throughout the process.
Our FDA Medical Device Regulatory Affairs Services
At Elexes, we have a team of FDA regulatory experts who have helped top medical device manufacturers get approval for their medical devices, avoiding delays and costly recalls. Our years of experience have created a fool-proof process for getting regulatory approvals in the US market.
Our unbeatable track record in helping companies launch their medical devices in the US market has made us one of the best FDA consultants worldwide.
Our FDA Regulatory Services
We can help medical device manufacturers and companies with the following services:
⦿ 510k submission (Pre-submission)
⦿ IDE
⦿ PMA
⦿ US agent services
⦿ Quality management services as per 21 CFR Part 820
⦿ Quality system audit Warning letter responses
⦿ Recalls and corrections
⦿ DeNovo submission
⦿ Import & Export support
⦿ Post-approval support
⦿ Medical device labeling support
Why Contact Our Experts For FDA Approvals?
Elexes' team of expert FDA consultants understands all the ins and outs of the US regulatory framework.
We understand the financial and operational challenges businesses face when meeting FDA requirements, including the costs associated with rigorous testing to establish the safety and effectiveness of your device compared to its predicate. We aim to streamline the 510(k) process while ensuring your cleared claims empower your salesforce and distributors to thrive in a competitive market.
Experience
We have a history of assisting medical device companies with 510(k) submissions across various CDRH review branches; Elexes is your trusted partner in achieving regulatory and commercial success.
Transparency
At Elexes, transparency is at the heart of our review process. We keep you informed in real-time throughout every stage, including interactions with the FDA. Even if we are there to assist you, all the submissions, communications, and documentation remain your property, ensuring you have full ownership and visibility at every step of the journey.
Product Classification
At Elexes, we understand how critical the concept of product classification is, so we have a specific team of experts to guide you through the classification process per the FDA regulations. Based on the device's classification, the action plan starts with assessing market potential, financial viability, and regulatory requirements for FDA 510(k) or PMA clearance.
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.
We’ve More
Than 256+ Global
Clients
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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.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
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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