We bring your Medical Device, Software (SaMD) and IVD products to the market and keep it there, by advising on “go to market strategy” & drafting documents needed for 510(k) clearances, CE Marking, ISO 13485, MDR compliance & more.


Every idea is a great idea! What it needs is a strong regulatory, quality, clinical and product partner to get it to the market and keep it there. Elexes Medical Consulting is more than just a regulatory and quality service provider; we are a trusted partner that works with Clients hand in hand to ensure their success. Read More

Global Regulatory Submissions

Projects Delivered

Audits Completed

Lawsuits Prevented

Elexes Services

01

Regulatory
02

Quality
03

Clinical
04

Product

Some Examples of Past Work

Here are some of the case studies from the wide variety of medical device and IVD companies that Elexes has helped in solving various regulatory, quality systems, design controls and clinical challenges.

  • In-vitro Diagnostics (IVD)

    Unique set of regulatory and testing requirements apply to IVDs. It is important to decipher CLIA waivers, RUO and IUO pathways for a successful IVD launch and compliance.

  • Active Medical Devices

    Ventilators, Patient Monitors, Hearing aids and other active devices need to comply with a complex set of performance specifications. Understand these preemptively for a speedy approval.

  • Wearables

    Manufacturers of wearables are often perturbed by categorization of the device under health and wellness product vs. medical device. Discuss this early on to get to the market aptly.

  • Software as a Medical Device (SaMD)

    While software is the core of an SaMD, due to classification of such products under medical devices, a plethora of requirements apply. Know the requirements and exemptions.

  • Implants

    In addition to biocompatibility which is the most important requirement for an implant, there are several other regulatory aspects that one must know of. Learn more to get it right the first time.

  • Combination devices

    Primary mechanism of action is the key when developing combination devices. Understand the design controls and the devices’ technical know-how for your combination device.

To view all our case studies click here

Resources

White Papers

Read our white papers to find answers to the common questions in regulatory & quality & explore worldwide marketing opportunities.

Videos

Learn what our team of experts have to say on medical device & IVD regulations & important quality systems compliance requirements.

News & Events

Click here to get the latest updates on medical device and IVD regulations, check out and sign up for our upcoming events.

Timeline

2015
ELEXES COMES TO LIFE

California based regulatory professionals and Stanford Alumni take the lead in helping medical device and software companies get to the market.

2016
ELEXES DOES 510(K)S AND CE MARKING

510(k) clearances are obtained and successful CE Marking allows Elexes’ Clients to legally sell their products in the US and EU markets.

2017
ELEXES DELIVERS ON MANY CER PROJECTS

With the advent of new guidelines Clients looking to update Clinical Evaluation Reports are served by Elexes for a variety of devices.

2018
ELEXES USES UNIQUE REGULATORY PROGRAMS

Elexes helps companies to early on engage with regulatory bodies and get expedited approvals or clearances by utilizing rarely known regulatory programs.

2019
ELEXES SUPPORTS FOR THE PRODUCT LIFECYCLE

Elexes offers design control support to companies and serves as an integral part of the team from pre-market to post-market stage.

2020
ELEXES INCREASES ITS BANDWIDTH

Elexes sets up ISO 13485 compliant internal quality systems or the QMS and increases on the personnel count to serve more Clients across the world.

2021
CLIENT TRUST & COLLABORATION CONTINUES

Every year Elexes’ long standing Clients expand their businesses by maintaining compliance and getting to new geographies by gaining in country approvals.

CEO Speaks

We are a group of Engineers and Researchers who aspire to strive to be of value everyday to the Healthcare Industry. For the several successful projects over the past years, I can say thank you to our team who served with integrity, sincerity, and professionalism, and to the Clients who trusted us to solve their small problems everyday before they became big. I spend my time and energy thinking about the next steps and how to address your regulatory, quality, traceability, product development and documentation obstacles effectively. I can say our greatest asset is the customer and the people!

Sincerely,
Parul Chansoria

What our customers had to say

Elexes team gave our organization great support. Apart from being knowledgeable, and thorough; they were very responsive. All these are excellent virtues which I would look for when choosing a consulting firm.

Tom Birney
NCEO, Masterlink | Phoenix,AZ

Elexes should be your next regulatory consultant. A timeline based project plan from their part greatly expedited the process.

Huiyou Zhu
CEO, TrioWave | Fremont, CA

Elexes promised and delivered - a go-to organization for FDA regulatory and quality systems work. They have outperformed every expectation we had.

Kurt Sysock
CEO, Radformation | New York

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. They are very professional and easy to work with.

Daniel Kinsey
President,ViDava | Sarasota, FL

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!

Linda Pan
Sr. Ex, Treedental | Hong Kong

They are prompt and 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. I highly recommend them!

Michal Depa
CTO, Jana Care | Boston, MA

Elexes team is always most helpful and proactive. They are thorough and have provided invaluable support to us on import, labels and registrations.

Philip McFerran,
MD, Blackrock Pharma | Slough, UK

Created regulatory compliant supplement fact sheets for multiple products.Very happy with the work. They were accurate and the turnaround time was amazing.

Elizabeth W
Owner, Liz Inc. | Phoenix, AZ
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