Design of Medical Devices
for Radiotherapy and Oncology Hardware
Disconnected development stages often cause expensive rework and regulatory delays. We bridge this gap by integrating mechatronic engineering into the early design of medical devices. Our unified workflow ensures your product moves from the initial sketch to a certified series production without friction.
What is Medical Device Design?
Medical device design creates physical solutions for healthcare needs by combining technical functionality with strict safety requirements. It defines how hardware interacts with patients and clinicians to ensure safe diagnostic or therapeutic outcomes. This discipline transforms a clinical idea into a validated product that meets international medical standards such as ISO 13485.
Some popular types of medical products include:
- Linear accelerators for oncology treatments
- Patient positioning systems for submillimeter accuracy
- Multileaf collimators for radiation beam shaping
- Ophthalmology beds for laser surgery
- Quality assurance phantoms for dose validation
The Process of Medical Device Design with gKteso
We move your project from the first sketch to a production ready device through a unified engineering workflow. Our approach eliminates obstacles between aesthetics and mechanical performance by validating every step early in the development cycle.
1
Concept Grounding
2
Mechanical Integration
3
Functional Validation
4
Documentation Setup
Product design solutions of gKteso
Modular RPS Platforms
These units provide submillimeter patient positioning for stereotactic radiotherapy.
Customized MLC Systems
Tailored collimators manage radiation field shapes for specific clinical needs.
Ophthalmology Motion Units
Ergonomic beds support LASIK and microsurgery through smooth motion control.
QA Phantoms
Tissue equivalent tools enable accurate dose calibration and system commissioning.
Why gKteso is the right partner for your project
Certified Safety
We manufacture every component according to ISO 13485 standards.
Deep Expertise
Over 30 years of mechatronic engineering flow into your project.
Unified Production
We handle everything from design to series assembly in house.
Tailored Engineering
Our team modifies every system to match your specific interfaces.
Application areas
for our design of medical devices
- Radiotherapy: Positioning systems and beam shaping tools for tumor control.
- Interventional Radiology: Ceiling mounted systems for real time imaging during surgery
- Ophthalmology: Patient beds and laser units for corneal corrections
- Quality Assurance: Tools for validating image accuracy and dose distribution
Radiotherapy & Oncology
Imaging & Diagnostics
Surgical & Operating Room Equipment
Patient Positioning Systems
Prototyping & Product Development
Regulatory & Compliance
Request Your Technical Design Quote
Plan your next medical device project with an engineering partner who understands mechatronic complexity. Request a consultation with our project engineers or ask for technical data sheets for our modular platforms. We provide a detailed offer for your specific OEM requirements including the full design of medical devices from concept to series.
Learn more about our design and engineering solutions for OEM partners
Discover how gKteso’s Design as a Service supports global MedTech companies in creating compliant, innovative, and manufacturable devices. From early ideation to validated production, we help OEMs realize new products faster and more reliably.
Learn more about …
Turning complexity into Clarity – with gKteso’s Design as a Service
Schedule an appointment now!
FAQ: Frequently asked questions for the design of medical devices
What are the principles of medical device design?
We prioritize human centered design that respects both clinical usability and manufacturing constraints. Every component meets strict safety standards while ensuring repeatable performance in the operating room. Our process eliminates the gap between aesthetic form and mechanical function.
What are the phases of medical device design?
What are design controls in medical devices?
What is design transfer in medical device creation?
How do I manage design controls for medical device products?
What are the standards for medical device design?
Designers must follow ISO 13485 for quality management and ISO 14971 for risk management. Additionally, the hardware must meet IEC 60601 standards for electrical safety in medical environments and ISO 62304 for Medical device software. We align our development with these requirements to facilitate CE, FDA approval.
Explore Our Contract Manufacturing Capabilities
Contract Manufacturing
Developed for medical technology innovators and OEMs, our Contract Manufacturing Services turn complex device concepts into certified, market-ready products. From rapid prototyping to validated large-scale production, we ensure regulatory compliance, precision, and supply chain reliability
Customized MLC
Tailored for OEMs, research centers, and novel radiotherapy platforms, our customized MLCs are co-developed to meet unique geometric, electronic, or integration needs. We support you from CAD concept to validated hardware, whether for FLASH, MRI-based therapy, compact systems, or proton beamlines.
Customized OEM QA tools
Customized OEM QA Phantoms and Water Phantom Transport Units from gKteso provide tailored solutions for commissioning, routine QA, imaging calibration, and OEM system integration. With reproducible precision, MDR/FDA compliance, MR compatible options and scalable manufacturing, they ensure reliability in clinical and research environments worldwide.