Innolitics staff has 20 years of experience in providing regulatory strategy, design documentation, and submissions for Software as a Medical Device (SaMD) and Software in Medical Devices (SiMD). We can help you make the correct choices to obtain timely and cost-effective market access in the United States, EU, UK, and Canada:
- Initial regulatory assessments,
- Creation of intended use (which drives the regulatory pathway),
- US, EU, UK, and Canadian device classification and regulatory pathway,
- Design documentation,
- Authoring and submitting the regulatory submission,
- Lead interaction with governmental agencies during submission review,
- Guidance related to creation of required Quality Management System (QMS),
- Post-market regulatory assistance (e.g., assessment and documentation of product changes).
Software Regulatory Strategy
We can help you answer these types of software regulatory questions:
- Is our software application a medical device or general wellness device?
- Will adding this feature affect our regulatory classification?
- Will adding this feature require additional cybersecurity or usability documentation?
- Is there some way to split my system into a “medical device component” and a larger non-medical device component, so as to reduce our regulatory burden?
There are a lot of regulatory firms that know about the software regulations, but there are very few that know about the software regulations and also know about software. We can speak both languages and help get your device as quickly as possible.