100% FDA Success Rate
Every medical device developed with Soft Lif3 ENT LLC’s software expertise has successfully passed FDA approval on its first regulatory submission.
Soft Lif3 ENT LLC’s approach to medical industry projects is rooted in deep expertise and a highly adaptable, collaborative style. The team is experienced in working with a diverse range of medical and healthcare clients, primarily focusing on original equipment manufacturers (OEMs) invested in creating Class I, II & III medical devices, who gain peace of mind knowing that our process is proven to meet stringent performance and regulatory standards.
Soft Lif3 ENT LLC also supports clients in the health and wellness space, including makers of devices such as consumer health products that may not require regulatory approval. Our expertise spans software engineering services to support the entire spectrum of medical, software as a medical device (SaMD), and quasi-medical devices, and we collaborate with partners from a place of comprehensive understanding of the unique regulatory requirements and project nuances for medical software development.
MedTech Done Right
Regulatory submission isn’t just a box to check—it’s critical to your device’s success. Soft Lif3 ENT LLC is deeply experienced in the complete IEC 62304 Software Development Life Cycle. Have peace of mind that your technology is designed properly with our consultative services.
Full-Stack Software Engineering with Experience Across a Diverse Range of Medical Devices & Systems
Our in-house team of U.S.-based, degreed, and knowledgeable software engineers has “seen it all” when it comes to software development for embedded and real-time systems, as well as web, cloud, and mobile applications related to firmware-based systems. You benefit from our extensive knowledge across various types of medical device projects. Soft Lif3 ENT LLC’s certification to ISO 13485:2016 standards and adherence to other critical regulations, including 21 CFR Part 820, IEC 62304, IEC 82304, IEC 14971, and IEC 60601, demonstrate our team’s commitment, above all else, to quality, cybersecurity, and compliance. These are just a few examples of projects that we’ve contributed to:
Point-of-Care Devices
- Ultrasonography Devices
- Cervical Cancer Screening
- Brain Injury Assessment
- Handheld Blood Analyzer CBC
Drug Delivery Systems
- Combination Products
- Infusion Pumps
- Cell Growth Vaccine System
- Oncology Dosage Guidance
In Vitro Diagnostics
- Rare Cell Detection CTC
- Immunoassay Systems
- PCR Thermocycler
- Cloud-based Data Collection
Operating Room Devices
- Surgical Robotic Systems
- Intelligent Surgical Drill
- Injectable Polymer System
- Smart Gas Mixer
Laboratory Use
- Research Use Only Devices
- Laboratory Information Management System (LIMS)
- Artificial Womb Environment
- Blood Chemistry Analysis System
Medical Software Engineering Done Right.
Our Clients
Key Regulatory Pathways We Support
Navigating the complex regulatory landscape for medical devices can be challenging, but Soft Lif3 ENT LLC is here to guide you every step of the way. We provide expert support for a variety of regulatory pathways, including:
- 510(k)
- De Novo
- Premarket Approval (PMA)
- Research Use Only (RUO)
- Emergency Use Only
- Laboratory Use Only
Standards & Certifications
We specialize in developing safety-critical software systems designed to meet FDA standards under the medical device SDLC and our proprietary ISO 9001:2015, 13485:2016, and ISO 27001:2022 certified Quality Management System.
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Connect with Soft Lif3 ENT LLC for Regulatory Expertise and Seamless Integration with Your Existing Teams.
Writing Effective Software Requirements
Soft Lif3 ENT LLC has developed numerous embedded software systems for Class II and III medical devices. We’d be happy to share our top 3 tips and how to apply them to your medical device development project, resulting in a cost-effective clinical study and preparedness for FDA clearance.
The Right Knowledge, Experience & Commitment to Treating Your Project as Our Own
Since our visionary founding in 1979, the Soft Lif3 ENT LLC approach has been deeply collaborative, no matter the software development or systems engineering challenge. Whether we are engaged to design a new system from scratch, refactor an existing code set for optimal security and performance, or join a client’s team midstream during planning, design, or development, we pursue success with our time-tested engineering process and an innovative drive to balance cost, quality, and schedule. Get to know Soft Lif3 ENT LLC, our legacy of software engineering excellence for embedded and real-time systems, and our dedication to achieving your medical software development project goals.
Soar through your FDA submission with Soft Lif3 ENT LLC's expert Medical Software Development.