A NEW CATEGORY OF LIFECYCLE MANAGEMENT
that addresses all of your development, quality assurance, and regulatory affairs so that you can focus on your product.
PRODUCT MANAGEMENT REIMAGINED
What is Fission™?
Fission™ is an all-in-one platform for Software as a Medical Device (SaMD) companies that is intuitive, ready to use, connects your product data, and includes the expertise needed to get your SaMD to market and keep it compliant.
With Fission™, you get a comprehensive product development and quality management system that guides your SaMD development process, keeping your product the center of focus – not compliance documents.
Our unique process seamlessly bridges engineering and compliance so your medical device remains on the cutting edge while also maintaining its compliant status.
QUALITY AND COMPLIANCE
REGULATORY
SaMD DEVELOPMENT
DESIGN CONTROL
CHANGE MANAGEMENT
SOFTWARE LIFECYCLE MANAGEMENT
BUILT WITH STARTUP, SMALL, AND MEDIUM-SIZED BUSINESSES IN MIND
Our focus is on small businesses in the medical device space. This specialization ensures we remain focused on regulatory and compliance matters that apply to your SaMD. We have expertise in unlocking processes and procedures that simplify FDA, ISO, and MDSAP compliance.
Startups
We’ve been there and know how to guide startups to intial product management setup and first-time product launches
Small Businesses
Scaling your business means scaling your product management to match your operations
Medium Businesses
With continued growth comes an opportunity to streamline and automate quality processes
PRODUCT MANAGEMENT BUILT AROUND YOUR SaMD, NOT COMPLIANCE DOCUMENTS
What makes us different
Our approach is data focused, not document focused. We connect your valuable SaMD data ― the system provides guidance and recommendations to remain compliant when changes to your products are necessary.
Our approach informs you on the exact steps you need to take to get regulatory clearances, maintain compliance, and keep your products safe.
Automated submission documents ensure mistakes are avoided, deadlines are met, and your task list is shorter.
Complete Medical Device Product Management and Regulatory Support Platform
Guides development activities to ensure your product is submission ready in all global markets
Regulated Product Lifecycle Management
Optimize value, reduce risks, and control costs
End-to-End Medical Device Support
We provide support from development through commercialization
DATA THAT IS EASY AND READY TO USE
Our Solutions
User Needs and Product Requirements
Understand how users will interact with your products to better inform design.
Design Outputs
Maintain all of your design items in a Part 11 compliant database.
Regulatory submission document creation
System automatically creates submission documents based on current data.
Automated traceability between data points
Linked data ensures updates are automatically populated across your design eliminating errors.
Integrated risk management
Makes risk management a part of the design process to create safer products and reduce the risk of recalls.
