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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
API Access
Has API
Integrations
Amazon
Andi
Composio
ContactOut
Crustdata
Fundable
Instagram
Klaus
Linkup
Nano Banana
Integrations
Amazon
Andi
Composio
ContactOut
Crustdata
Fundable
Instagram
Klaus
Linkup
Nano Banana
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
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
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management