strategic compliance
IVD Roadmap to ensure your product gets to market within the business goals
Roadmapping is the strategic process of determining the actions, steps, and resources needed to take the initiative from vision to reality. Based on business strategy and goals, generate an execution plan for end-to-end device concept to market.
The roadmap will capture strategic compliance and is designed to guide seamlessly through the entire device lifecycle, from the initial concept to regulatory submissions, market entry, and post-market surveillance.
We ensure that timelines are met, resources are managed, and there is effective communication.
To ensure transparency and to manage your budget, the IVD roadmap will be quoted as a project as opposed to hourly rate.
Compliance culture
Having compliant processes, templates and completed necessary documentation may be enough to get you over the line for a regulatory submission but if your team/s haven’t been educated on why compliance is vital day to day of the importance of compliance maintenance then you will have endless issues day to day.
We can help integrate compliance into your business goals.