Team Elexes 
DHF Consultation & Remediation
Design History File (DHF) remediation can have a strong impact on your medical device company. If not done accurately, it can cause a serious problem of rework that will have a direct financial impact on your company.
As per notified bodies, not having a complete Design History File (DHF) will cause their withdrawal of their ISO certification which means that CE mark for these medical device companies will no longer be applied to product labeling.
We, at Elexes medical device consulting agency have experts who will help you with your DHF completion.
We expertise in offering support for all the documentation required for your DHF as per FDA part 820 and/or ISO 13485. Not just this, we also perform consent decree remediation and product support.
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. 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…
Our expertise include
Design Controls
- Design and Development Plan
- User Needs and Stakeholder Needs
- Design Inputs
- Design Outputs
- Design Verification & Design Validation
- Test Method Validation
- Trace Matrix
Risk Management
- Risk Management Plan and Report
- Design Failure Mode Error Analysis (DFMEA)
- Process Failure Mode Error Analysis (PFMEA)
- Use Related Risk Analysis (URRA)
- Product Hazard Analysis (HA)
- Risk Analysis Matrix
- Clinical Risk Benefit Analysis (CRBA)
Design Transfer
- Creation of Device Master Record (DMR)
- IQ/OQ/PQ
- Process Validation
- Mold Approvals
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.
Expertise
Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.
Customized Solutions
We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.
Why Choose Elexes?
Efficiency
We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.
Compliance Assurance
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
Confidentiality
We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.
Looking for someone who can assist you?
Contact us
Elexes Team
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 -
Associated Regulatory Authorities.
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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