Our solutions will enable you to bring safe, effective medical devices to market with ease and speed.
End-to-End Medical Device Support
We provide support from development through commercialization
Regulated Product Lifecycle Management
Optimize value, reduce risks, and control costs
Complete Medical Device Product Management and Regulatory Support Platform
We ensure products are positioned to maximize performance across the product lifecycle
Let us handle the details
Now that you have developed a new medical device, we will help you put together proof of safety and efficacy. We will work with you to establish proof that you have designed a safe product that meets user needs and requirements. We’ll assist in pulling together your device design data and minimize risks all without the frustration of manual compliance work.
Product lifecycle that is fast, smooth, and collaborative
Fission provides guidance and recommendations to remain compliant when changes to your products are necessary. Built in automations mean inherent peace of mind. Gone are the frustrations of manually checking compliance, painstakingly updating forms, or spending countless hours guessing your way through audits.
We are excited to expand our core solution offering as we continue to innovate based on our client’s needs and feedback. Here is what you can expect from us in the near future.
Full Outsourced Quality Management Organization
Take the burden of QMS compliance and even audits off of your hands.
Take risk management to the next level and objectively compare the risks and benefits of your device.
Manufacturing and Supply Chain
Monitor your supplier and production performance, identify areas to focus on quality improvements and cost reduction.