If developing smart medical devices that improve patient care and offer a better quality of life is your business, then choosing Svep Design Center as your partner is the smart move. We support you from idea generation and needs specification to product launch and upgrades.
Use our team of experts to co-create and get the best medical devices to market quickly, including product testing and small test series production.
Expertise throughout development
The balance between form, function and price needs to be just right for products to meet all quality and regulatory requirements within healthcare. At Svep we can take on every facet of product development including hardware, firmware, software and user interface design.
Our expertise covers signal processing, embedded systems and AI so you can produce devices that solve today’s healthcare challenges.
Helping you improve people’s lives
Bringing in our team means you can concentrate on your core skills and leave design to us. From large complex development projects to straightforward product upgrades, we help you reach your development goals in every phase – on time, at the right quality and on budget.
Our areas of excellence include everything from project management through system design and connectivity, ultrasonics to regulatory compliance.
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With us, your development processes become better, a whole lot faster and more reliable.
Complying with the most rigorous standards
Companies develop medical devices to save lives. In order to do that, hospitals and healthcare institutions have to know that they are safe, have been rigorously tested and have a proven beneficial effect on the people using them. We are certified by all major standard organizations to help the smooth development, implementation and auditing of medical devices. The requirements we are certified for include but are not limited to the following:
- ISO 13485 and EU-MDR 13485 EU MDR is a requirement that regulates what you need to do to produce or import medical devices into the EU. ISO 13485 is a global requirement where an organization must show it produces medical devices and offers services that consistently meet customer and regulatory requirements.
- Risk management: ISO 14791 ISO 14971 This is an ISO standard for applying risk management to medical device manufacturing. It lays out the the requirements to determine the safety of a medical device by the manufacturer during the product lifecycle.
- IEC 62304 governs the requirements for the medical device software lifecycle process It is harmonized by the EU and US and is a benchmark to comply with requirements in both these markets.
Patients get better connected with Tunstall
Tunstall has 150,000 connected devices in Sweden that work with health professionals and social care providers to manage long-term health conditions and provide person-centred care. Svep Design Center provides a secure and trusted device management platform to monitor received alarms and provide mission-critical information to Tunstall operations centres, care givers and municipalities.