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A trusted regulatory and quality compliance partner for your Hospitals/Clinics

We, at Elexes offer a complete range of regulatory, assessment & quality compliance support to hospitals and clinics. Right from performing detailed audits, HIPAA security services, medical coding, to risk adjustment, we offer all kinds of services to improve your hospital’s and clinic’s compliance to applicable requirements.
Let’s talk how we can help!
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50+
Years Of
Collective Experience

250 +

Successful projects

200 +

Products Type

100 +

Global Clients

Associated Regulatory Submissions

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250 +

Successful Projects

200 +

Product types

90 %

Audits cleared

100 +

Global Clients

Get All Under One Roof

Our Expertise

Reasons why you should consider hiring a professional regulatory consultant. There are several challenges that hospitals and clinics face during their day-to-day activity.

Environmental and Occupational Safety Assessments

We help hospitals evaluate the hospital's adherence to safety regulations and guidelines related to hazardous materials, waste disposal, and occupational health.

PSQIA Compliance

The Patient Safety and Quality Improvement Act of 2005 (PSQIA) is a reporting system designed to ensure an appropriate degree of data is available to be accessed to resolve any patient safety and health issues. Per PSQIA, patient safety organizations (PSOs) are to be shortlisted and allowed by the Agency for Healthcare Research and Quality (AHRQ) to collect and review patient safety information. Our team will help install a perfect patient safety system to ensure you are in compliance with regulatory laws.

Regulatory Reporting Support

Assisting in preparing and submitting required reports to government agencies, accrediting bodies, and other relevant entities is one of our expertise.

Policies on Data Privacy and Security

We have experts who will guide you through documentation of compliance with data privacy laws, such as the Health Insurance Portability and Accountability Act (HIPAA), to protect patient information.

The HITECH Act Compliance

The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 exists to ensure the adoption and meaningful use of healthcare information technology. There are subtitles within the HITECH Act that deal with the electronic transmission of health information and the associated privacy, security, and operational risks. We at Elexes ensure that your hospital or clinic is in compliance with HITECH Act.

Emergency Preparedness and Disaster Planning

The Emergency Medical Treatment & Labor Act (EMTALA) was enacted back in 1986 as a means to ensure greater public access to emergency services regardless of their ability to pay for it. We have professionals who will help you assess if your hospital is following EMTALA act and if not, we help resolve it.

Policy and Procedure Development

Assisting the hospital in developing and updating policies and procedures to align with current applicable regulations and best practices is what our experts can help you with. This ensures that the hospital's practices are in line with industry standards.

HIPAA Compliance

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) may well be the most well-known data privacy law. We, at Elexes have professional who will help you be compliant to the Security Rule, establish a set of security standards & processes for protecting certain information that is maintained or transferred via electronic format.

Accreditation Preparation

We also Help the hospitals be prepared for accreditation surveys by accrediting bodies like The Joint Commission (TJC) or other relevant organizations. This includes ensuring that the hospital meets the necessary standards and guidelines required for accreditation.

Clinical Documentation Improvement (CDI) Programs

We have experts who can assist you with CDI (clinical documentation improvement) by determining the working Diagnosis related groups (DRG)(before discharge) & providing real-time feedback for code questions as needed.

Quality Improvement Programs

We assist hospitals in developing and implementing quality improvement initiatives to enhance patient care, safety, and outcomes. This may involve conducting audits, assessing root cause analysis, and developing action plans for improvement.

Compliance Training and Education

We have dedicated team of experts who can provide training sessions for hospital & clinics’ staff to ensure they understand and comply with regulations, policies, and best practices related to their roles.

Equipment Maintenance and Calibration

We help review & help improve documentation of equipment maintenance, calibration, and service records to ensure equipment safety and accuracy.

Credentialing and Privileging Records

We help prepare the records of the credentialing and privileging process for healthcare professionals practicing at the hospital or clinic.

Informed Consent and Patient Rights

Our experts will assess, review, and refine informed consent forms to make sure that patients have a clear understanding of their treatment options and rights.

Discharge Planning and Follow-Up

We help prepare records of discharge plans and post-discharge follow-up for patients to ensure there are no compliance gaps.

Staff Credentials and Training

Documentation of staff credentials, licenses, certifications, and ongoing training is critical for any healthcare organization. We have professionals who assist you with this.

Medical Record Keeping

Our experts ensure that the hospital maintains accurate and complete medical records in compliance with applicable laws and regulations. This includes proper documentation of patient care, treatment plans, and progress notes.

Minutes of Meetings

It is vital to document the meeting minutes for any healthcare organization. We help hospitals document all the important information discussed in various hospital meetings, including governing board meetings, safety committee meetings, and quality improvement meetings.

Insurance and Legal Documentation

Records related to insurance coverage, legal agreements, and contracts are very essential to be documented properly to avoid any compliance issues. We have experts who can help you create a proper system for the same.

Healthcare Billing and Coding

We review all the documentation processes related to healthcare billing and coding to ensure accuracy and compliance with coding guidelines and government regulations.

Support During Investigations and Audits

Elexes offers assistance to ensure proper compliance documentation and responses are prepared for your healthcare organization for external audits or regulatory investigations.

Compliance Monitoring and Audits

We conduct comprehensive assessments to identify the hospital's current compliance status with applicable regulations, laws, and industry standards. This includes evaluating policies, procedures, and practices to identify areas of improvement.

Mock Surveys and Readiness Assessments

We Conduct simulated accreditation surveys and readiness assessments to help the hospital or clinic identify potential compliance gaps and address them proactively.

Regulatory Updates and Alerts

Providing regular updates on changes in healthcare regulations and industry standards to keep the hospital informed and proactive in maintaining compliance is another thing that we assist with.

Infection Control Audits

We Conduct audits of infection control practices to ensure compliance with infection prevention and control guidelines set by the regulatory bodies.

HIPAA Compliance Audits

Our experts Conduct audits to assess the hospital's compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations for safeguarding patient health information.

Medical Record Audits

We review hospital’s medical records for accuracy, completeness, and compliance with documentation requirements, coding standards, and billing practices to ensure there are no compliance gaps and remedy them if there are any risks.

Cybersecurity compliance documentation

We help your healthcare organizations to create proper cybersecurity documentation by auditing all the documents that already exist, finding gaps, and providing best options to resolve them.

HIPAA Compliance Audits

Our experts Conduct audits to assess the hospital's compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations for safeguarding patient health information.

Popular Clients

We’ve 200+ Global Premium Clients

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In place of Better solutions for your insurance service

Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance.

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Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Quick Turnaround

Experience timely results with our efficient services.

Confidentiality guaranteed

We offer 100% confidentiality understanding how critical the data is for you.

Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Why choose

Elexes for medical device regulatory & compliance services?

Quick Turn around

Experience timely results with our efficient services.

Confidentiality guaranteed

We offer 100% confidentiality understanding how critical the data is for you.

Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Contact Us

Associated Regulatory Submissions

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What are clients are saying about our services?

Client Testimonials

What Our Clients Say About Us?

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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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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. “

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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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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. “

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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. “

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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. “

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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. “

Looking For Regulatory Assistance?

Let's Talk How We Can Help You?

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FAQs

Frequently Asked Questions!

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Contact Us
How much will it cost to get support from professional medical device consultant?
The cost of medical device consulting usually varies as per the Intended market & type of the product. To know more, please connect with an expert at Elexes.
How do regulatory agencies classify medical devices?
Regulatory bodies determine the class of medical device based on the risk they pose to the user or patient. You can find out more about the classification here
Are post-market surveillance and vigilance required?
Yes, it helps in assessing your product’s performance post launch and stay 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 the product.
Do you offer regulatory services in UAE?
Yes, we do. You can check the complete list of countries we serve here
How Much Experience Our Team Member ?
In Elexes Medical Consulting we have a collective experience of 50+ years in providing regulatory & compliance assistance to all the industries.

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