Medical Apps & CE Marking for the HealthTech Industry
Today we announce the exciting news. Shortcut Sweden has completed its acquisition of Careful Apps. We have strengthened our company with the MedTech expertise that Careful Apps brings. Uniting the forces, we present Shortcut Medtech – a specialized department ready to offer the market a unique combination of high-quality app development services together with a deep understanding of the healthcare industry as well as the European regulatory requirements. At Shortcut Medtech, we build and CE mark medical apps.
Our intentions are not only to drive business expansion in a profitable niche but also to deliver long-lasting value to our customers’ projects. Healthcare and medical services are facing an inevitable digital transformation. Clinics need to be more accessible to their patients, available 24/7, and able to ensure clear communication and fast responses.
The potential with medical apps is immense. They support patients and healthcare providers by collecting valuable health data, aiding in follow-ups, functioning as diagnostic support, providing treatment (such as Cognitive Behavioral Therapy) and so much more.
All apps with medical purposes must comply with the European Medical Device Regulation (MDR) and be CE marked. They need to be safe, reliable, and usable. The company (or manufacturer) needs to have in place a quality management system and a technical file of their app. At Shortcut Medtech, we help companies reduce their time to market by offering them CE marking together with app development.
Shortcut Medtech aims to be a reliable partner for companies working with medical apps and is regarded as a stamp of quality for venture capital companies looking to invest.
Our clients can get a full-circle service: from initial market research to app launch and post-market surveillance and maintenance. We provide services such as GAP analyses of current documentation, user research and prototyping, design and creative services, and technical development, together with building quality management systems and technical files. As a client, you can be sure that your product is in perfect health and that it grows together with your business.
We develop apps that aim to transform the healthcare system and have a positive impact on service providers and patients alike.
We have helped many enterprises with app development and CE marking: from big pharma companies such as Allergan/AbbVie and Roche to health tech startup companies such as HerCare looking to scale up.
Please contact me at paulina.jonasson@shortcut.no to know more about Shortcut Medtech and how we can help you take the next step with your medical app business.