Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Orthogonal specializes in offering development services that concentrate on the creation and expansion of Software as a Medical Device (SaMD) and interconnected medical device systems, blending cutting-edge engineering techniques with rigorous adherence to regulatory standards. Their methodology encompasses the entire product lifecycle, which includes elements such as user experience design, integration of human factors, requirement specification, risk assessment, Agile software development, and thorough verification and validation processes to guarantee both operational effectiveness and safety. By utilizing Agile methodologies tailored for regulated settings, they facilitate iterative development, promote quicker feedback loops, and encourage ongoing enhancements while ensuring compliance with regulatory frameworks like the FDA, EU MDR, and ISO standards. Moreover, Orthogonal aids in the development of various applications, including mobile, web, and desktop solutions, along with cloud-based systems, artificial intelligence algorithms, and SDKs that facilitate integration with external platforms, empowering medical devices to connect seamlessly, analyze data, and provide valuable insights. This comprehensive approach allows for innovative solutions that not only meet industry standards but also enhance patient care and operational efficiency.
Description
ZipQuality offers a software-driven service designed to aid medical device manufacturers in launching innovative products. Our collaborative platform adeptly manages swift design modifications for agile teams while upholding regulatory standards. With a pre-configured system that incorporates processes and tools, there’s no necessity to modify your existing quality system. The integrated platform efficiently accommodates rapid design iterations for product documentation. Our team of seasoned consultants supports your team throughout the entire process. Built on the robust ENOVIA platform, our comprehensive, scalable software tools are tailored to meet your needs. This integrated solution allows for quick design adjustments while ensuring that product documentation and data remain synchronized and that all records are maintained in a state ready for audits. We cover essential areas such as product, hardware, and software requirements. Our expertise extends to the complexities of software-heavy medical devices. The ZipQuality framework is founded on a structured documentation approach that enhances systems engineering, promotes effective risk management, and ensures transparent traceability, making it an invaluable asset for any medical device company. Additionally, our commitment to continuous improvement means we regularly update our service offerings to align with industry advancements.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Amazon
Yes
Andi
Yes
Composio
Yes
Crustdata
Yes
Cursor
Yes
Didit
Yes
Fiber AI
Yes
Google Calendar
Yes
Instagram
Yes
Klaus
Yes
Integrations
Amazon
No
Andi
No
Composio
No
Crustdata
No
Cursor
No
Didit
No
Fiber AI
No
Google Calendar
No
Instagram
No
Klaus
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Orthogonal
Founded
2025
Country
United States
Website
www.orthogonal.com
Vendor Details
Company Name
Consensia
Country
United States
Website
consensiainc.com/zipquality/
Product Features
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
No
Training Management
No