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Clients Testimonials

Amazing Feedback Say About Services

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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! “

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.

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) requests, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

Read Here

Our Services

Our Compliance Assessment Process

Initial Consultation

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.

Regulatory Expertise

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.

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Document Review

We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Gap Analysis

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.

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.

Ongoing Support

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.

Contact Us

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 -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

Popular Clients

We’ve 200+ Global Premium Clients

Saneso
Niramai
Apex dental sensors
Neurasignal
SS inovations
Amaryllis
Inclode
iMedisync
DJOGlobal logo cmyk_TM
Summus Laser Logo
Saneso
Niramai
Amaryllis
Apex dental sensors
SS inovations
DJOGlobal logo cmyk_TM
Neurasignal
iMedisync
Inclode
Summus Laser Logo

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