Regulatory Strategy Workshop for your medical device or IVD
The perfect start for a successful product approval
To succeed as a manufacturer of medical devices or in vitro diagnostics, it is essential—not just to have a well-thought-out business plan—but also to consider regulatory requirements (standards, laws, EU regulations, etc.) from the very beginning.
Requirements that are already taken into account during product development (design, materials, etc.) save unnecessary detours and setbacks later on.
You will work out the standards, laws, and other requirements relevant to you in this workshop, receive important practical tips, and get an overview of how these requirements affect your product, your design, your schedule, and possibly even your funding plan.
Workshop-Contents
- Regulatory Basics for Medical Devices
- Which standards, laws, and directives apply to your product?
- Inventory of existing documents and structures in the area of technical documentation and quality management
- Creation of a Regulatory Strategy Plan that shows the impacts on your product, design, timeline, and potentially your funding plan
With this plan, you will be able to estimate much more accurately how much time, how many internal and external resources, and what costs you should plan for the approval process.
After that, you can create funding applications or develop detailed planning for critical work packages such as, for example, the
- Introduction of the ISO 13485
- Applications for clinical studies
- Start of the creation of the technical documentation for MDR/IVDR.
We would be happy to provide you with individual offers to further support you with the implementation of ISO 13485 or the creation of the technical documentation for MDR/IVDR!
