There is a great unmet need in the medical device industry when it comes to product development and regulatory compliance.
- Solutions are siloed between development and regulatory teams
- eQMS software generally provides digitized templates of documents without guidance or direction on how to complete
- Multiple consultants are necessary but vary in ability, knowledge, and skill, and are costly.
This has left significant gaps in processes and frustration for small med device companies who want to focus on their product. Because if this, we’ve developed Fission to provide a fully outsourced Development and Compliance Solution.
Fission™ was developed to not only fill in the gaps, but to completely rethink the approach.
- Fission™ is an outsourced Development and Compliance Solution that provides a full-service application plus an expert team that has experience from medical device startup trenches.
- Guides customers’ product development process, putting their products at the center instead of compliance documents.
- The data-oriented application makes valuable information easily accessible ― not buried in documents ― and is used to automatically produce the documents needed for regulatory submission.
Our mission powers us
Fission™ enables small and medium-sized medical device companies to efficiently bring to market safe and effective medical technology by providing them with comprehensive regulatory compliance and design control.
Fission™ makes valuable quality information easily accessible ― not buried in documents ― and automatically makes changes throughout the system that are triggered by a single change.
Fission enables small and medium-sized medical device companies to efficiently bring to market safe and effective medical technology by providing them with processes that remove the guesswork from device development.
- Data is superior to documents – technology has evolved to the point where documents are obsolete
- Your product should be at the center of development and compliance activities
- Your data should be accessible, streamlined, and efficient
- You should reclaim your time to be able to focus on your business and product, not your quality system
- AI/ML is expanding – a compliance platform should reduce your burden by generating your submission documents for you, not the other way around
- You should have the support you need – when you need it
WHY CHOOSE FISSION
- Your product is our focus
- We believe that meeting Quality and Compliance requirements can be value added activities
- We have a team of experts with diverse backgrounds and areas of specialization to provide for all of your Medical Product needs
- Standardized workflows and processes take the guesswork out of Medical Device development
- Our dedicated support team ensures that you remain in compliance
- No need for outside consultants to manage your processes, with Fission its all included.