Are you working for a startup company or want to launch one in the Medtech industry? Or are you supporting such companies as an investor or consultant? Then you are an essential contributor to innovation in the Medtech field – congratulations!
However, you should be aware of the hurdles to develop regulatory compliant devices. In addition, getting through regulatory approval processes is often extremely time and resource consuming. Startups tend to have even more limited resources compared to larger, established organizations and their products are often new and innovative with no predecessor information on which to base their documentation.
Medtech-specific software tools support the efficient creation of the necessary documentation with higher quality and accuracy – which accelerates device development and market access. Best practice tips help to understand regulatory requirements and get through the process. Furthermore, the risk of nonconformities during a post-market launch audit is significantly reduced.
- How to get started with regulatory documentation?
- What information do I need to create and provide?
- Is what I am doing correct and sufficient to get market access?
These and many other questions arise during the establishment of regulatory processes and creation of the technical documentation for medical devices.
The latest product from avasis - avaMedical Startup - is the key to harness the extensive industry expertise of our team along with the established technology with Siemens Polarion to get your Medtech startup up and running for generating audit-safe technical documentation.
In this webinar find out more on how avasis and their Polarion products can help you for implementation of state-of-the-art digitalized processes in the medtech industry. We will discuss:
- Requirements Engineering for medical devices
- Verification & validation tests and required traceability to requirements
- Regulatory framework: regulatory requirements and their efficient integration into product development
- Developing safe medical devices: Risk management and integration into product development documentation
