From idea to a compliant medical device

Without the bottlenecks

One team for development, compliance and cybersecurity.
For MedTech companies developing connected medical devices.

MDR, ISO 13485, IEC 62304 and IEC 81001-5-1 – all covered.

Svep is a medical device software and product development partner for teams building connected devices where hardware, firmware, software, cloud, cybersecurity, risk management and verification need to work together. We help move from prototype to a compliant, production-ready product path with structure from day one.

Where MedTech projects get stuck

Most MedTech projects don’t fail on technology – they fail on structure.

Common challenges

ISO 13485 is complex and costly to implement
IEC 62304 is hard to apply in practice
Cybersecurity requirements unclear
Risk management process lacks structure
Slow, unclear path from prototype to product.
Verification and validation is an afterthought

This is where we come in

ISO 13485 certified development partner
Structured IEC 62304 from day one
Actionable cybersecurity
Risk management built into development
Clear path to compliant product
Verification built into development from day one

Move faster. Stay compliant.

We don’t start from scratch

Move faster – without adding risk or complexity.

Quality management system already in place
Combined electronics + software + cloud competence
Proven risk management framework
Templates and SOPs for MedTech development
Lean development process aligned with IEC 62304
Cybersecurity process from the start
Extensive verification and test lab capabilities
In-house environmental and EMC testing

Get started quickly

Clear entry points – depending on where you are

MedTech Kickstart

When you need to establish the foundation

Risk framework (ISO 14971)
IEC 62304 structure and setup
Processes and documentation

Start structured from day one

Cybersecurity Assessment

When cybersecurity requirements are unclear

Gap analysis against IEC 81001-5-1
Identify threats and vulnerabilities
Documentation and implementation support

Make cybersecurity concrete

Development Acceleration

When you need to move towards a compliant product

System development (Electronics, Software and cloud solutions)
Compliance-aligned development
Test and verification

Move to a compliant product

Not sure where to start? Get your next steps in MedTech

Cybersecurity for connected medical devices

Modern medical devices must be secure by design. Svep supports manufacturers with cybersecurity risk management, secure software development and compliance with standards such as IEC 81001-5-1.

Standards and regulatory expertise

Developing medical devices for global markets requires both technical expertise and a deep understanding of regulatory requirements. Svep supports customers throughout the development process with experience in standards and frameworks including:

IEC 62304
ISO 14971
IEC 62366
IEC 60601
IEC 81001-5-1

Technology from Svep is used daily by over 2 million users

Our experience includes

Surgical instruments for treating prostatic enlargement
Critical life-support systems for emergency care
Wearable devices
Dialysis treatment systems
Reliable and resilient cloud operation with 24/7 uptime requirements and NIS2 compliance

We support customers throughout the entire product lifecycle, from concept development and system architecture to embedded software, electronics, cloud connectivity, testing, and continuous product evolution.

Tunstall – connected healthcare systems

As a long time development partner Svep supports Tunstall in the development of connected healthcare devices and cloud solutions used in real-world care environments.

Trusted engineering partner for connected and regulated healthcare technology.

Operating under certified management systems (ISO 13485, 9001, 14001, 27001)

Get in touch

We have created brand new system solutions,
steered ongoing projects back to track,
and developed over a hundred different products over the years,
sold in hundreds of millions of units worldwide.

At Svep, innovation, design, and quality, go hand in hand.

We are your development partner in software and electronics.

Ready for a new challenge?

Does it sound interesting to work at Svep?
Are you curious about new technology?
How does a friendly company with Swedish “high ceilings” sound?

Would you like to know more?

Get in touch!