Team Elexes 
Popular Clients
We’ve 200+ Global Premium Clients
Medical Device | SaMD | LDT & IVD
A Trusted Regulatory & Quality Compliance Consultant Across Globe
Elexes is counted among the best medical device regulatory and quality compliance consulting experts across the globe. We have helped several top medical device manufacturers get their product to market in time.
Our expertise in all the necessary regulatory and quality areas of medical device manufacturing has led us to be trusted by many medical device companies around the globe.
Elexes Medical Consulting is one of the reputed and trusted names in regulatory & quality compliance industry. Over the period of 5 decades, we have helped several companies get approval for their products.
A reputable medical regulatory & quality compliance consultant known for solving their client’s most difficult problems, by offering expert guidance and unbiased assistance when it comes to regulatory clearance & compliance.
Elexes Medical Consulting’s journey began with the goal of offering services worldwide and assisting clients in getting approvals for their breakthrough innovations in the medical device industry.
250 +
Successful Projects
200 +
Product types
90 %
Audits cleared
100 +
Global Clients
Our History
Elexes was founded in 2015 by Parul Chansoria, a regulatory and quality compliance expert specializing in IVDs and medical devices. Over the last decade, Elexes has grown into a trusted partner for companies in the medical device and healthcare industries, offering a range of services from regulatory affairs consulting to quality management and compliance audits.
Accreditation & Certification
Elexes is one of the recognized regulatory and quality compliance consulting companies that withhold several industry-recognized accreditations and certifications. As a trusted partner for medical device companies, we ensure that our services adhere to the highest quality standards.
ISO 13485 Certification
Elexes is an ISO 13485-certified company, ensuring that our services meet the highest quality standards and compliance for medical device companies. We have obtained this certification from BSI Group, a globally renowned certification body.
ISO 13485 reflects our dedication to providing the best regulatory and quality services.
CQA Certification
We also hold the Certified Quality Auditor (CQA) certification that is issued by the American Society for Quality (ASQ). CQA-certified professionals are trained to assess the effectiveness of Quality Management Systems (QMS) and ensure compliance, quality, and efficacy. Our CQA-certified professionals are adept at proactively addressing issues, helping companies achieve better resource utilization, enhanced efficiency, and cost savings while maintaining regulatory compliance.
RAC
Certification
Our team is certified with the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS). The RAC credential is globally recognized and validates expertise in regulatory affairs, particularly in the medical device, IVD, and biotechnology industries. The RAC exam rigorously tests a professional's knowledge of global regulations, including those from the US FDA, European Union (EU) (e.g., MDR/IVDR), and international guidelines.
Elexes’ Founder, Parul Chansoria is RAC certified and continues to renew the certification annually, ensuring up-to-date knowledge of the ever-evolving regulatory landscape.
Lead Auditor - MDR and ISO Certified
Our auditors are certified in ISO 9001, ISO 13485, EUMDR, and EUIVDR, making Elexes an ideal partner for audits related to ISO 13485, MDSAP, MDR, IVDR, and ISO 9001. With the regulatory landscape changing, especially with MDR and IVDR, having auditors with these certifications ensures a smooth transition through compliance requirements.
Our auditors are well-equipped to guide you through updated technical documentation, clinical evaluation reports (CERs), and labeling compliance, offering a comprehensive and proactive approach to quality and regulatory challenges.
A Few of Our Successes
Symbyo
Software as a Medical Device (SaMD) used by dentists to create 3D models of the oral maxillofacial region for planning dental surgeries and placement of dental implants.
Theradome
A wearable device used to promote hair growth in females with androgenic alopecia. The device uses laser technology for treatment and is offered in different models.
Triowave
A device used for relieving a variety of musculoskeletal pain originating because of strain from exercises or normal household work. The device is available OTC.
Masterlink
Sensors used for a radiographic examination by a dental professional. The device is meant to assist in the diagnosis of diseases of the teeth, jaw and oral structures.
Radformation
A software only device intended to perform a quality assessment and provide important insights on radiotherapy treatment plans meant to be utilized for cancer patients.
Skanray
A Mobile Surgical C-Arm X-Ray System intended to provide Fluoroscopic and Radiographic images of the patient during diagnostic, surgical and interventional procedures.
Skanray
A patient monitoring system that can monitor at the bedside or during intra-hospital transport multiple parameters and vital signs in an Adult, Pediatric or Neonatal patient.
Skanray
High Frequency extra oral X-Ray medical device is used for IntraOral X-Ray in Dental radiography for diagnostic purposes. The device is offered for prescription use only.
Intracel
A medical device used in dermatological and general surgical procedures for percutaneous fractional treatment of the skin, electrocoagulation, and hemostasis.
Lipocel
A medical device used for reduction in waist circumference by utilising High Intensity Focused Ultrasound that works by acting on the Subcutaneous Adipose Tissue.
Cefaly
A wearable medical device meant for the treatment of migraine in patients, 18 years of age or older. The device is also used as prophylactic treatment of episodic migraine.
Cefaly
An over-the-counter (OTC) wearable device used for the treatment of migraine. A mobile application to work with the device to help patients keep log and control the device.
Triworks
A non-invasive medical device used in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for certain skin types.
JNS Dental Lab
A Mouth Guard medical device intended for the protection against bruxism and teeth grinding by creating a barrier between the upper and lower dentition for the patient.
Saneso
A complete system of devices consisting of different variations of Colonoscopes and Gastroscopes used for visualization of lower and upper gastrointestinal tract.
Cefaly
An over-the-counter (OTC) wearable device (provided with functionalities of RFID, etc.), and used for the treatment of migraine in patients, 18 years of age or older.
Saneso
An accessory to an FDA cleared endoscope. The accessory is now provided for multi use (supported by robust reprocessing validation) instead of the original single use.
Classys
A medical device used to deliver high intensity focused ultrasound energy to disrupt subcutaneous adipose tissue and provide a non-invasive aesthetic effect.
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
What clients are saying about our services?
Clients Testimonials
What are Clients Saying About Us?
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.
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
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!
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
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.
“
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. “
