Medical
At Nectar, we provide end-to-end support in developing medical devices and software, guiding projects from inception to FDA approval using our phase-gated approach and ISO 13485 Certified Quality Management System. With expertise in SaMD, user experience, and risk management, we deliver innovative, efficient, and HIPAA-compliant digital health solutions.
​Regulatory Excellence and Quality Assurance
Nectar excels in medical device development by prioritizing Regulatory Compliance and Quality Standards. We strictly adhere to criteria established by the FDA and international benchmarks, such as ISO 13485 for Quality Management Systems specific to medical devices. Our commitment extends to complying with IEC 60601, ensuring the safety of our medical electrical equipment.
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This approach demonstrates our dedication to navigating regulatory frameworks with precision, delivering clients medical devices that meet and surpass stringent quality and safety standards in the industry.
Expertise in Medical
Device Development
We bring a wealth of expertise to the table, showcasing a deep understanding of clinical workflows and a mastery of medical device regulations. Clients seeking transformative healthcare solutions find a reliable partner in us, as we leverage our experience to pioneer advanced medical technologies, setting new benchmarks for innovation within the industry.
Risk Management and Prototyping Precision
Our core strategy revolves around anticipating and addressing risks. Nectar follows ISO 13485 for Quality Management and ISO 14971 for robust Risk Management, ensuring meticulous identification and resolution of potential pitfalls. Our Prototyping and Testing processes, aligned with ISO 60601, highlight our commitment to safety and efficacy. Clients trust our meticulous approach, knowing their innovative medical devices are in capable hands.
User-Centric Design
and Clinical Validation
At Nectar, user experience is paramount in medical device development. Our focus on Usability and Human Factors Engineering, following IEC 62366 standards, ensures advanced yet user-friendly devices for healthcare professionals and patients. Expertise in Clinical Validation and Trials, coupled with meticulous compliance and validation processes, positions us as a reliable ally for innovating healthcare technology.