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.

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.

elexes regulatory

Our Team Member

Meet Our Leaders

Parul Chansoria

Founder and CEO

Dr. Mark Harman

Clinical Advisor

Amit Padhy

Associate Tech Manager

Client Testimonials

What Our Clients Say About Us?

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

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.

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.
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.
Yes, it helps in assessing your product’s performance post launch and staying compliant with updated regulations.
It usually depends on your regulatory approval preparedness and the regulatory authority’s timeframe set for the particular type of product.
In Elexes Medical Consulting we have a collective experience of 50+ years in providing regulatory & compliance assistance to all the industries.

Latest News & Blog

Read Our Latest Articles