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 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.
Our expertise include
Our Compliance Assessment Process
Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.
We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.
Why Choose Elexes?
We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.
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.
Amazing Feedback Say About Services
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York