A Guide to the FDA Medical Device Approval Process
Master the FDA medical device approval process with confidence. This guide breaks down device classes, the 510(k) pathway, PMA, and post-market success.
October 9, 2025
We build secure platforms with advanced DICOM viewers and integrated CRM solutions tailored to healthcare needs
Building medical imaging platforms is difficult. Most companies spend years trying to create production-ready solutions, and the expertise required is rare. On top of that, every project needs unique DICOM viewing features that off-the-shelf viewers don’t provide, all while keeping patient data private and secure.
At PYCAD, we address these challenges directly:
We build for your specific use case: dentistry, orthopedics, virtual autopsy, radiology and other medical imaging domains.
Multi-planar views, 3D rendering, annotations, segmentation, and PACS integration.
Manage patients, reports, and cases in one place.
Automatic segmentation, measurements, and LLM-based text summarization/report generation.
HIPAA-ready, GDPR-friendly, with user management and role-based access.
Once the project development is concluded, we offer different tiers of support services based on your needs.
DICOM viewer + CRM + AI segmentation for CBCT scans (teeth, jaws, airway, mandibular canal, …).
AI bone segmentation and implant planning in a custom DICOM viewer.
CRM + DICOM Viewer built from scratch with measurement tools, annotations, segmentation, and PACS integration.
From the beginning, the team demonstrated a high level of professionalism, experience, and dedication. We would especially like to highlight the following points:
Quality of work: The final result met our expectations, complying with the highest quality standards in the implementation of the application and complying with requirements.
Adherence to deadlines: They managed the project efficiently, delivering all phases and the entire project within the agreed deadlines, which was crucial for our own timeline.
Communication and collaboration: Communication was fluid and transparent throughout. Their team was proactive in keeping us informed, receptive to our suggestions, and very collaborative, which greatly facilitated the process.
Customer service: Their willingness to resolve any questions or challenges, and their flexibility to adapt to small changes, has been exemplary. We felt very well taken care of.
In short, working with the company has been a positive experience. We are satisfied with the results and would not hesitate to recommend them to other companies looking for a reliable and professional partner.
Pycad enhanced our 3D medical solution with impressive accuracy and precision. Their expertise, innovation, and exceptional service made a significant impact. I highly recommend them as a trusted partner.
I was really impressed when I saw all the individual details of the work. It blew my mind, I was floating the whole morning after seeing it. I love the advancement we’ve made together, and I really hope we can keep this going long-term. It’s been a really good experience working with you.
Successful job completion... I am pretty happy with the performance... We would like to continue working with you as we develop more experience and become more clear about our aim, want to have your consultation to make progress.
Pycad's AI expertise transformed our project, improving diagnostic accuracy and workflow efficiency. Their tailored solutions and exceptional service made a significant impact. Highly recommended.
Working with the Pycad team was a fantastic experience. From the very beginning, they took the time to fully understand our goals and technical needs. They developed the model within an appropriate time frame and seamlessly integrated it into our preferred platform. Beyond just delivering the product, they went above and beyond to help us with setup, troubleshooting, and ensuring everything ran smoothly. The entire process was efficient and collaborative. I highly recommend Pycad for anyone looking for a knowledgeable and dependable partner in AI model development.
Pycad enhanced our 3D medical solution with impressive accuracy and precision. Their expertise, innovation, and exceptional service made a significant impact. I highly recommend them as a trusted partner.
I was really impressed when I saw all the individual details of the work. It blew my mind, I was floating the whole morning after seeing it. I love the advancement we’ve made together, and I really hope we can keep this going long-term. It’s been a really good experience working with you.
Successful job completion... I am pretty happy with the performance... We would like to continue working with you as we develop more experience and become more clear about our aim, want to have your consultation to make progress.
Pycad's AI expertise transformed our project, improving diagnostic accuracy and workflow efficiency. Their tailored solutions and exceptional service made a significant impact. Highly recommended.
Working with the Pycad team was a fantastic experience. From the very beginning, they took the time to fully understand our goals and technical needs. They developed the model within an appropriate time frame and seamlessly integrated it into our preferred platform. Beyond just delivering the product, they went above and beyond to help us with setup, troubleshooting, and ensuring everything ran smoothly. The entire process was efficient and collaborative. I highly recommend Pycad for anyone looking for a knowledgeable and dependable partner in AI model development.
From the beginning, the team demonstrated a high level of professionalism, experience, and dedication. We would especially like to highlight the following points:
Quality of work: The final result met our expectations, complying with the highest quality standards in the implementation of the application and complying with requirements.
Adherence to deadlines: They managed the project efficiently, delivering all phases and the entire project within the agreed deadlines, which was crucial for our own timeline.
Communication and collaboration: Communication was fluid and transparent throughout. Their team was proactive in keeping us informed, receptive to our suggestions, and very collaborative, which greatly facilitated the process.
Customer service: Their willingness to resolve any questions or challenges, and their flexibility to adapt to small changes, has been exemplary. We felt very well taken care of.
In short, working with the company has been a positive experience. We are satisfied with the results and would not hesitate to recommend them to other companies looking for a reliable and professional partner.
PYCAD builds custom web platforms for medical imaging, centered around advanced DICOM viewers and seamlessly integrated CRM systems. We specialize in creating domain-specific solutions for fields such as dentistry, orthopedics, and virtual autopsy, often enhanced with AI for tasks like image segmentation and report generation. Our focus is on delivering reliable, production-ready platforms that healthcare companies can use to power their daily workflows.
Dentistry, orthopedics, forensic medicine, liver/pancreas imaging, and more.
Yes! We have a range of support options tailored to your specific needs.
Yes, our platforms are designed with HIPAA and GDPR in mind.
Yes, we develop and deploy AI APIs for automatic image segmentation, text/report generation and more.
DICOM, Nifti, Nrrd and more.
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Dubai, United Arab Emirates
