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Medical Device

Electronics, Software, Firmware

Design & Development

bsi assurance mark genesys electronics design

From IDEATION to LAUNCH, we're with you every step of the way.

With over 25 years’ experience, Genesys Electronics Design is a trusted provider of medical device electronics, software and firmware design services.  

We understand the quality, traceability, documentation and rigorous testing requirements necessary to bring a new medical device to market. As your electronics, software and firmware partner, we go the extra mile to ensure you get the market-ready output you expect and compliance support you need to launch your medical innovation.  

Our Services

medical device product definition

Product Definition Product conceptualisation, specification & development planning.  

Risk Management Planning, management and mitigation of project and product risk. (ISO 14971)  

medical device circuit design

Circuit Design Hardware architecture, schematic design, modeling & capture.  

medical device pcb layout

PCB Layout Mechanical architecture, PCB design & 3D modeling.  

medical device software development

Software Development Test-driven development of applications, firmware and VHDL. (IEC 62304)  

medical device verification testing

Testing & Verification Function & performance; physical, environmental and regulatory compliance.  

medical device standards compliance

Regulatory Compliance Regulatory EMC, safety & risk management - among other considerations. (IEC 60601-1)  

medical device production engineering

Production Engineering Documentation packaging & test jig design for manufacture 'anywhere'.  

medical device manufacturing

Manuacturing Sourcing, production management & assembler liaison and design support.  

Why Choose Genesys?

ISO 13485 ACCREDITED

ISO 13485 is the internationally agreed standard for a quality management system specific to the medical devices industry. Commercial medical devices must comply with this standard.

BSI Assurance Mark ISO 13485
25 years in the business

25+ YEARS EXPERIENCE

We have over 25 years’ experience designing and developing complex electronics, software, firmware and IoT systems.

ONE PASS TO PROUCTION™ GUARANTEE

We guarantee One Pass To Production™ from initial concept, through to volume production of commercially-ready products.

one pass to production guarantee

Case Studies

TRUSCREEN

truscreen photo

Genesys improves ease of use, accuracy and speed for TruScreen cervical screening technology.

EXOFLEX

Exoflex

Award winning Exoflex transforms hand rehabilitation therapy with innovative technology, improved data.

CARIAC OUTPUT MONITOR

cardiac output monitor

Innovative Cardiac Output Monitor provides accurate, non-invasive cardiac output measurement.

Start today!

If you have a medical device concept, prototype or product and need some expert guidance or hands-on support to get it to market, contact us today for a no-obliation discussion with a medical device specialist.