Medical Device Engineering:
From Concept to Regulatory Compliance

With over 10 years of experience, transforming complex hardware, software, and documentation challenges into market-ready medical devices.

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Areas of Expertise

Medical Device Development

Comprehensive project leadership from concept to final product. Expertise spans chronic wounds, respiratory systems, photobiomodulation, and endoscopy, ensuring complete oversight of the development lifecycle.

Electrical Safety & EMC Compliance

Avoid delays and unexpected costs with expert guidance through complex standards. Strategic adjustments to hardware and software minimize failure risks in safety and EMC testing.

Device & Process Documentation

Expertise in IEC 60601, ISO 13485, and FDA regulations ensures comprehensive documentation preparation, helping your device not only function properly but successfully reach the market.

Cost-Effective Labs (ISO/IEC)

Access to ILAC-approved laboratories in Brazil enables testing at costs up to 80% lower than US or EU options while maintaining full validation for MDR and FDA requirements.

Rapid Prototyping

Functional prototypes validate hypotheses quickly, leveraging extensive hardware and firmware development experience to create relevant proof-of-concept steps toward commercialization.

Team Management

Strategic assembly and management of specialist teams ensures optimal solutions delivered within timelines that align with your specific requirements.

Featured Projects

Wound assessment device - Innovative medical device

Wound assessment device

Advanced imaging technology for precise wound measurement, tracking, and bacterial load evaluation

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Chronic wound care therapy device - Innovative medical device

Chronic wound care therapy device

Advanced wound therapy system based on violet and IR light with smart monitoring

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Mechanical insufflation-exsufflation device - Innovative medical device

Mechanical insufflation-exsufflation device

Portable airway clearance device for patients with respiratory muscle weakness

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Class II mechanical ventilator - Innovative medical device

Class II mechanical ventilator

COVID-19 Mechanical ventilator designed for patients not dependent on mechanical ventilation

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Thinnest disposable rhinoscope - Innovative medical device

Thinnest disposable rhinoscope

Single-use nasal endoscope with high-resolution imaging for ENT procedures

Veterinary ventilator and anesthesia machine - Innovative medical device

Veterinary ventilator and anesthesia machine

Cost-effective, purpose-built solution specifically for veterinarians that needed a portable anesthesia and ventilatory device

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Class II mechanical ventilator - Innovative medical device

Home sleep monitoring system

Distributed polysomnography solution designed for home use with enhanced patient comfort

Low-power laser and LED [hotobiomodulation device to attenuate Parkison's symtoms

Home photobiomodulation therapy device

At-home light therapy device to reduce Parkinson's disease symptoms using low-level laser and LED technology

Veterinary ventilator and anesthesia machine - Innovative medical device

Full-body motion tracking system

High-precision 27-sensor system for real-time body movement tracking and analysis based on Kalman Filters.

Ready to bring your project to life?

Whether it's a new device, a compliance challenge, or the need for a functional prototype, I'm here to help. Let's discuss how we can accelerate your development.

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