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 product platform for Medical Device companies that is intuitive, ready to use, connects your product data, and includes the expertise needed to get your product to market and keep it compliant.

With Fission™, you get a comprehensive product development and quality management system that guides your product 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

PRODUCT DEVELOPMENT

DESIGN CONTROL

CHANGE MANAGEMENT

SOFTWARE LIFECYCLE MANAGEMENT

BUILT WITH 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 product. 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 PRODUCT, NOT COMPLIANCE DOCUMENTS

What makes us different

Our approach is data focused, not document focused. We connect your valuable product 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.

Contact Us Today to Learn More