Elexes Team 
Team Elexes 
A Professional Support for No Delays or Compliance Gaps
Data Integrity & GMP
It is vital that medical device companies maintain proper data integrity during the manufacturing process of any medical device. Our experts at Elexes Medical device Consulting will help you adhere to all the standards issued by the global regulatory bodies and will help you stay within the cGMP while preserving your data’s integrity.
With the set of services we offer and the consulting process we follow, you can rest assured that all your regulatory regulations and compliance issues are addressed professionally - including cGMP manufacturing compliance and medical device’s data integrity.
Our cGMP & Data Integrity Training Services
We, at Elexes, one of the most trusted medical device consulting companies have a proper and well-established training module that ensures proper compliance to both cGMP and data integrity regulations set by global regulatory bodies. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Associated Regulatory Authorities.
Our cGMP Training Program Includes
- Good documentation practices (GDP)
- Annual Good Manufacturing Practice (GMP)
- Investigations
- Corrective Action & Preventive Action (CAPA)
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
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.
Parul Chansoria
Founder
We help companies streamline their entire regulatory & compliance processes.
Looking for someone who can assist you
with regulatory compliance?
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Clients Testimonials
Amazing Feedback Say About Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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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 expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
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Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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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 excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with 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! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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