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

Risk Management

Design Transfer

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Experience Team

Our Services

Product Quality Monitoring

Product Quality Monitoring

We provide guidance on establishing quality control processes to monitor the consistency…

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Corrective and Preventive Actions (CAPA)

Corrective and Preventive Actions (CAPA)

In case of any product-related issues or non-compliance, we help you plan…

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Customized Post-Market Surveillance Plans

Customized Post-Market Surveillance Plans

We create tailored post-market surveillance plans to meet your specific product and…

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Product Recalls and Withdrawals

Product Recalls and Withdrawals

If necessary, we assist in planning and executing product recalls or withdrawals…

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Market Feedback Analysis

Market Feedback Analysis

We analyze customer feedback and market trends to identify potential product improvements…

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Regulatory Updates and Compliance

Regulatory Updates and Compliance

Our experts stay up-to-date with evolving cosmetic regulations and ensure your products…

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Post-Market Surveillance Reporting

Post-Market Surveillance Reporting

Our team helps in preparing and submitting necessary post-market surveillance reports to…

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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.

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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

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