We at Key2Compliance are happy to announce that we have formed a collaboration with Uppsala Innovation Centre (UIC), one of the leading business incubators in Sweden, to produce videos for its knowledge hub. We are honored to be given this opportunity to partner with UIC while sharing a common goal of providing start-ups and scale-ups with the knowledge and guidance necessary to market its medical devices.
Initially launched in October of 2022, the Knowledge Portal is a Swelife-funded project with an educational platform that streamlines knowledge acquisition for researchers, innovators, and startups in Sweden. Modules on drug registration and documentation, medical technology, as well as gender equality, have since been added to the platform.
At present, the platform is being further bolstered with material on commonly requested fields, with Key2Compliance adding video tutorials on medical device regulatory compliance for start-ups. The tutorials cover a wide range of topics, ranging from determining if your innovation is classified as a medical device, to conducting a Post-Market Surveillance (PMS) and a Post-Market Clinical Follow-up (PMCF).
Key2Compliance’s Helena Dahlin, Director Regulatory Affairs, emphasized the importance of having a strong understanding of the medical device regulatory compliance process. “Medtech is an area where it is important to ‘get it right’ from the beginning. It’s about knowledge of regulations, documentation, clinical validation, and regulatory strategies. Key2Compliance has developed 8 tutorials covering the most important areas, where software as a medical technology product is also highlighted,” she says.
If you are a startup or scale-up and need more knowledge and guidance to market your medical device, don’t hesitate to contact us and we can guide you through all stages of the process, from idea to market.
You can find out more info about the Knowledge Portal click here.
