Team Elexes 
Regulatory | Quality | Compliance
A Trusted Medical Device Regulatory & Quality Compliance Consultant
Elexes has been a trusted name amongst the best medical device regulatory and quality compliance consultants. Over the years, we have helped top medical device companies develop different types of devices like SaMD, IVD, LDTs, etc, and get their products approved in the desired markets. With a team of experienced medical device regulatory consultants, we have managed to become the go-to agency for many companies all around the globe for several services like regulatory approvals, regulatory due diligence, clinical trial documentation, QMS system support, ISO-13485 or MDSAP certification, and more… Our expertise in providing end-to-end solutions from the product development stage, regulatory approvals to product launch & beyond (post-market surveillance) makes us stand out amongst other medical device regulatory consulting agencies across the world.
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Associated Regulatory Authorities
250 +
Successful Projects
200 +
Product types
90 %
Audits cleared
100 +
Global Clients
Our Expertise
What do we offer?
Medical Device Regulatory Services
We offer a complete range of medical device regulatory & quality compliance support. From production life-cycle to post-market compliance support, we offer all kinds of regulatory support to medical device companies and manufacturers. Our experts also offer documentation support.
IVD Regulatory Services
At Elexes, regulatory experts specialize in In-vitro diagnostics devices (IVDs). We offer full support to medical device companies developing IVDs from the IVD development stage to regulatory compliance and post-market services. With our experts, you get to navigate the complex regulatory landscape together, ensuring compliance with all necessary regulatory requirements established for IVDs.
SaMD Regulatory Services
Software as a medical device (SaMD) is one of the emerging medical device categories. The RA/QA professionals at Elexes offer the best regulatory consulting services for SaMDs. Our experts help medical device companies with everything from classification, SaMD registration, and regulatory gap analysis to post-market compliance.
LDT (Laboratory Developed Tests) Regulatory Services
Elexes offers specialized consulting services for organizations that are developing Laboratory-Developed tests (LDTs). Our team provides end-to-end support, ensuring your LDTs meet LDT regulatory standards and deliver precise and reliable diagnostic results.
Regulatory & Quality Compliance Consutng
Why Choose Us?
We help manufacturers be compliant to all the regulatory standards and quality standards.
Stay compliant with industry regulations and standards.
Achieve regulatory success with Elexes, all within your budget.
Experience timely results with our efficient services.
We offer 100% confidentiality understanding how critical the data is for you.
Our Team Member
Meet Our Leaders
Parul Chansoria
Founder and CEO
Vivek Goyal
Co-Founder
Dr. Mark Harman
Clinical Advisor
Amit Padhy
Associate Tech Manager
Client Testimonials
What Our Clients Say About Us?
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing. “
Linda Pan
Sr. Exe Treedental, Hong Kong
“I’m a fan! We worked with Elexes on import-export regulations, and couldn't have asked for a better expert. Elexes' team was very patient in answering all our questions and guided us on every step. Will definitely work with them again!
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Tom Birney
CEO Masterlink, Arizona
“Great work! Elexes team gave our organization immense support. Apart from being knowledgeable, and thorough; they were very responsive. All these are excellent virtues that I would look for when choosing a consulting firm.
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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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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 are very responsive and have done a great job with our regulatory projects and document control set-up. They were easy to contact and were quite quick at understanding the nuances of our product. “
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They’re always helpful and proactive. They are thorough and have provided invaluable support to us on import, labels, and registrations. “
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! Created regulatory-compliant supplement fact sheets for multiple products. Their work helped us to sell within domestic & international markets without any problems. They were accurate and the turnaround time was amazing. “
Kurt Sysock
CEO Radformation, New York
“ Elexes promised and delivered a go-to organization for FDA regulatory and quality systems work. They have outperformed every expectation we had. “
Popular Clients
We’ve 200+ Global Premium Clients
FAQs
Frequently Asked Questions!
Learn what most of our clients ask while taking regulatory and compliance services.
How much will it cost to get support from professional regulatory consultant?
The cost of regulating consulting usually varies as per the Intended market, industry you are in & type of the product. To know more, please connect with an expert at Elexes.
How do regulatory consultant help with product development
Regulatory consultants keep a check for any compliance risks during product development. They also assist you to create the right development strategy in compliance with the regulations of the market you wish to launch your product in.
Is post-market surveillance and vigilance required?
Yes, it helps in assessing your product’s performance post launch and staying compliant with updated regulations.
How long will it take for my product to get approved?
It usually depends on your regulatory approval preparedness and the regulatory authority’s timeframe set for the particular type of product.
How much experience do you have?
In Elexes Medical Consulting we have a collective experience of 50+ years in providing regulatory & compliance assistance to all the industries.
