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Development of medical devices
Development of medical devices
With over 10 years of experience in developing and leading teams across various medical device projects, I have contributed to advancements in areas such as chronic wounds, respiratory systems, and endoscopic rhinoscopes.
Throughout my career, I have taken on diverse roles, including Electrical Engineer, Customer Service and Management, Product Owner, and CTO, gaining a comprehensive perspective on the medical device development lifecycle.
Electrical safety and EMC compliance
Electrical safety and EMC compliance
Failing electrical safety or EMC tests can be both costly and time-consuming. With firsthand experience in these challenges, I can guide you through these complex standards and help fine-tune your hardware, firmware, and software to minimize failure risks while maintaining cost efficiency.
When needed, we can also conduct pre-compliance EMC or safety tests in certified laboratories, offering valuable insights at a relatively low cost to ensure your project stays on track.
Device and process documentation
Device and process documentation
With extensive experience in IEC 60601-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 62304, IEC 62471, IEC 60601-2-57, IEC 60601-2-18, FDA Software Requirements, and other key standards and guidances such as ISO 13495, I can help navigate complex regulatory landscapes.
I understand that no development holds value unless the device reaches the market. I can identify applicable regulatory requirements, present them clearly and concisely, and collaborate with you to develop the necessary documentation for your project's regulatory approval.
Cost-effective ISO and IEC labs
Cost-effective ISO and IEC labs
Brazil offers excellent ILAC-approved laboratories, whose reports are recognized by both MDR and FDA. These labs provide a cost-effective solution for testing your medical devices, often at a fraction of the cost typically found in the USA.
I have personally experienced this advantage, obtaining laboratory results at just 15% of the cost of a U.S. lab while successfully securing FDA approval for our medical device.
Key turn prototype and more
Key turn prototype and more
I can develop quick, ready-to-test prototypes to validate your hypotheses and advance key steps in your development process of medical and non-medical devices.
If a specific task is beyond my scope or not the best fit for me, I can assemble a team of skilled specialists to address your challenge effectively.
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