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.
Need Help?
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
Linda Pan
Sr. Exe Treedental, Hong Kong
Tom Birney
CEO Masterlink, Arizona
Diane Bryant
CEO Novasignal, Los Angeles
Joshua Mink
Manager Outset Medical, California
Michal Depa
CTO Jana Care, Massachusetts
Philip McFerran
MD Blackrock Pharma, England
Samip Shah
VP Regulatory AliveCor, California
Elizabeth W
Owner Liz Inc., Arizona
Kurt Sysock
CEO Radformation, New York
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.