Design History File (DHF) Medical Device Remediation

Great documentation is crucial for a successful submission. Our clients rely on our experienced team to proactively develop plans that align with FDA or other international standards for their submissions.We specialize in navigating challenges midway through projects, particularly when product development outpaces documentation or when reliable design controls are lacking. With a track record of partnering with over 100 clients, we excel in guiding projects towards successful submission.

Featured DHF Remediation Services

Design History File (DHF) Creation & Updates

Streamline the process of creating and updating design information using design controls, ensuring your device maintains and complies with industry standards. See our FAQ below for what a DHF should include.

Submission Success Driven by Documentation

Documentation developed by an ISO13485 registered quality system defining a strong design control process provides a stress-free pathway to FDA and Global clearance for your device.

FDA/CE Mark Compliance Gap Analysis

Ensure regulatory compliance through comprehensive assessments of your device DHF. This will include proper documentation detailing the device design, development process, every design control step and demonstrating accordance with an approved design plan and product requirements.

TESTIMONIALS

Hear From Our Happy Clients

Our clients’ experiences speak volumes about our commitment to innovation and quality. Read firsthand accounts of how Vantage MedTech has positively impacted various medical technology projects.
My relationship with Vantage MedTech spans three different companies and 15 years. I return to the Vantage MedTech team because they consistently deliver innovative solutions in a timely and cost-effective manner. I plan to continue this relationship for many years to come!
Vantage MedTech has provided us with a broad range of expertise, from electrical and software design to quality assurance and regulatory affairs. It would have been unlikely we could have hit our scheduled milestones without their help.
We were a young start up with a great technology, but were running into issues that our manufacturing partner could not explain. Over a year later and still no clear solution, I engaged Vantage MedTech to perform an independent analysis. Within 24 hours, they not only identified the issue, but also presented solutions to correct it. Vantage MedTech came forward with the level of expertise that was necessary to help turn around the situation, allowing REACT to bring our advanced neuromuscular therapy to patients who need it.
I have had the pleasure of working with Vantage MedTech team for the past seven years. The Vantage team is extremely professional, responsive, and collaborative. I know that I can always count on the Vantage MedTech Team to provide a quality product that will meet the product requirements.

Director of R&D

Several Medical Device & Life Sciences Firms

CEO

Katalyst Surgical

Kenneth C. Paulus

Founder & CEO, REACT Holdings & Pelvic Wave

Peter J. Oehlberg

Director, Technical Operations Bracco Diagnostics Inc

Ready to ensure your medical device meets regulatory standards?

Contact us today to schedule a consultation and discover how our DHF Remediation services can complete your product development road to regulatory clearance.

Rely on partners who can adapt to your needs, wherever you are in your journey

Our depth of expertise in specific clinical segments is strengthened by our dedicated team, refined processes, and specialized portfolio and proprietary platforms.

30+
Years of experience
150+
Specialized medical device engineers
1,600+
Medical devices successfully developed
98%
On time delivery
Experienced Partner

Reduce execution risk by working with a medical device software company known for over 1,600 medical devices successfully developed.

Advantage Platforms®

Leverage our proprietary platform architecture and reduce development timelines by up to 60%.

Expert Team Collaboration

Our in-house team of specialized engineers will bring your medical device from concept to reality with precision and care.

Certifications

Vantage MedTech is proud to be recognized for our certified excellence in medtech innovation and manufacturing.

 

* Held by RBC Medical Innovations
** Held by Sterling Medical Devices

FAQ

Frequently Asked Questions

What is Design Control?

The Quality System (QS) Regulation includes regulation on design controls, which detail FDA’s required activities for medical device design and development. Design control regulations provide specific details on how FDA expects manufacturers to implement Quality by Design (QbD) during the product’s lifecycle design phase. Design control is an iterative process following a structured methodology to ensure the device underdevelopment will be safe, effective, and meet end-user needs. Design Control activities must be documented and recorded in a design history file (DHF).

When is DHF Remediation important?

DHF Remediation is crucial for maintaining compliance with regulatory regulations and product requirements and ensuring the safety and effectiveness of medical devices. It helps identify and address any gaps or discrepancies in the DHF, reducing the risk of non-compliance issues during regulatory inspections and product audits.

What does DHF Remediation involve?

DHF Remediation typically involves activities such as performing gap analyses, identifying and addressing design-related issues, and ensuring alignment with regulatory requirements. It may also include documentation review, risk assessment, and verification and validation activities.

What should a Device DHF include?

A device DHF should include the following at minimum:

  1. Design plan and subsequent iterations.
  2. Design inputs, design outputs, and product specification documents.
  3. Verification and validation testing protocols and reports
  4. Design transfer records
  5. Design change information
  6. Design review minutes

How long does DHF Remediation take?

The duration of DHF Remediation can vary depending on the complexity of the medical device, the extent of the remediation required, and regulatory timelines. A thorough assessment and remediation process may take several weeks to months to complete, depending on the specific requirements.

Who can benefit from DHF Remediation services?

Medical device manufacturers, including startups, small businesses, and established companies, can benefit from DHF Remediation services. It is especially valuable for companies seeking to ensure compliance with regulatory standards, improve product quality, and mitigate risks associated with non-compliance issues.

How can I get started with DHF Remediation?

To get started with DHF Remediation, you can contact a reputable medical device consulting firm or service provider that specializes in regulatory compliance and quality management. They can assess your specific needs, provide guidance on the remediation process, and help you develop a customized plan to achieve compliance with regulatory requirements.