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Experience you can trust

We recognize that no one can do it better than you, your staff and your intellectual knowledge are the keys to your success. Our services and expertise are focused on providing you with services surrounding your core software product to free up your key talent so that their focus is on innovation and core competencies. Using our services to outsource routine but essential functionality and services will increase your overall internal software engineering capacity and enables you to grow your staffing needs through SMEDIX.

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Our Services

Accelerate your product development

SOFTWARE ENGINEERING

Proven track record in writing medical device software (Application, Embedded, Mobile and cloud). Experienced staff with years of experience in developing IVD software in a FDA regulated environment. We are cross platform and develop in .Net, Java, HTML5, Android, iOS and other technologies to meet our clients’ needs. We work seamlessly and with your team in an Agile development environment to help you meet your project milestones.
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SOFTWARE VERIFICATION AND VALIDATION

Our experience and knowledge of Medical Software Development, Governing Processes and Guidelines enable us to customize Software V&V solutions that best meet your product and Regulatory submission needs.

SOFTWARE RISK ANALYSIS

Our experts will work closely with your teams to develop software risk documentation relative to the software safety classification (A, B or C) to ensure compliance with Risk Management Process per ISO 14971 and IEC 62304.

PROCESS and COMPLIANCE

Our Software Solutions and Services are compliant with FDA, TUV, UL and other governing regulatory agencies. We work closely with your Regulatory and Quality functions to ensure that software Design Inputs and Outputs meet set Guidelines and Standards.

SOFTWARE TEST AUTOMATION

Test Automation can be very effective to help reduce overall cost and time for conducting software verification activities. SMEDIX can help you implement Software Test Automation solutions within your budget constraints and the product’s overall lifecycle.

Globalization and Localization

In order to reach a global audience with your software and applications, our expert team can help you with the localization and globalization processes. With the most advanced technologies SMEDIX can get your product ready for an international market.

About us

We know what it takes to foster a strong and effective working relationship when outsourcing software engineering services. Founders of this company successfully led large distributed Software Teams for over 20 years developing medical software in health care (Clinical Diagnostic, drug delivery systems). Our flexibility, experience and skills can greatly complement your efforts throughout the various stages of the Software Development Lifecycle and help you realize your product ideas and goals.

Our primary mission is to help our customer’s succeed; we have the know-how and the insight on what it takes to realize Medical Software Products that meet the safety, quality and usability attributes in the medical software industry.

Meet Our Management Team

Decades of medical software experience

FAYEZ SWEISS
Chief Executive Officer

Fayez Sweiss founded SMEDIX in 2013 and holds the role of President and General Manager. Previously, Fayez served as the Director of Software Development for Gen-Probe Inc. (Currently Hologic) for 10 years in which he led development efforts for multiple medical instruments software as well as integration of various Assays that were globally launched in the EU and US. Prior to Hologic, he headed various software development teams for Abbott Laboratories Hospital Product Division (Hospira) from 1993 to 2003. Under his leadership the company launched many new devices including infusion systems, cardiac monitors and various applications for the drug delivery and medication management systems. Fayez began his career as Software Engineer for Anacomp where he successfully progressed with the company for 9 years holding positions including, Systems Support Specialist, Senior Software Engineer, Project Engineer and Project Manager. He holds a BSc in Software Engineering and Certifications in Process and Project Management from the University of California San Diego and California Institute of Technology.

Dr. Shane Dultz
VP Engineering

Shane Dultz joined SMEDIX in 2016 to serve as vice president, engineering at the San Diego office. In this role he is responsible for managing engineering talent at SMEDIX to deliver custom validated software solutions to meet the quality and regulatory needs of our key partners within the in-vitro diagnostics (IVD) industry. Shane is an experienced systems engineering professional, leader, and innovator who started his career as a scientist over 20 years ago. For over a decade, he has led teams to develop medical devices for the IVD, pharmaceutical, and life-science research markets, holds 9 patents, and authored 14 publications. He worked 6 years at Stratec Biomedical USA, an OEM manufacturer of automated blood analyzers and other ISO 13485 compliant medical devices. As Director of Technology, he was responsible for bringing new technologies to market, managing global teams of hardware and software engineers, and developing technology roadmaps for the organization. Shane received his master’s and Ph.D. degrees in physics from UCLA and has enjoyed a diverse career starting as an experimental physicist in quantum computing at Jet Propulsion Laboratory and later transitioning to biotechnology in 2003.

Shane Schanback
Director Software Test Engineering

In 2013, Shane Schanback joined SMEDIX to lead Software Verification and Validation efforts. His track record included the completion of various successful V&V projects for Molecular Diagnostics and Sequencing instruments. Prior to joining SMEDIX he was a Test Engineer at HOLOGIC (Formerly Gen-Probe) were he tested software for Molecular Diagnostic Instruments. He was promoted to lead testing efforts for the Remote Diagnostics and Serviceability software of the Diagnostic Instruments where he gained experience in remote diagnostic software and the software tools that are used to troubleshoot customer issues and maintain software remotely. Shane started his career in software V&V at Certified Compliance Solutions/Hospira, Inc where he tested the software of various infusion pumps and a web-based software that kept track of the various infusion systems. He was promoted in 2010 to lead testing efforts for Hospira’s MedNet™ Safety software. He graduated top his class in 2003 with a degree in Computer Networking Systems from ITT Tech after a successful career with the U.S Army where he gained leadership skills, commitment to excellence, and dedication to getting the job done.

Florin Cighi
VP Software Engineering (EU)

Florin joined SMEDIX in 2015 as the lead engineer for contract engineering for Ventana/Roche advance staining platform (HE600®). His strong leadership, proven track record and diversity in the various technology stacks enabled him to effectively lead various projects for SMEDIX. He was promoted to manage operations and projects for the SMEDIX EU office. Prior to joining SMEDIX, Florin led the Software Development US division for contract software engineering for Stratec Biomedical USA where he developed software for various clinical diagnostics instruments for eight years. As a software engineer his accomplishments included the development of a distributed sales force automation application (HERMES®) for Transart, an ERP application (BRBMANAGER®) for Barandi Solutions, web applications and platforms in auto sales market for Trax Info Tech in Romania. Florin holds a BSc from the University of Mathematics and Informatics, “Babes-Bolyai” University, Cluj-Napoca, Romania and is Co-author of a computer programming problems volume, “Informatics Assignment, a Solved Issue” (2004).

Adrian Cighi
Director of Software Development (EU)

A highly motivated IT project manager with 15+ years experience in IT sector and software development, leading successful IT projects in various businesses across multiple countries.

Adrian has a strong focus to improve the software development process and constantly looking to improve the quality and productivity by using tools that give a very good control and predictability and let the team focus on the core activities.

In-depth knowledge of software development process frameworks and industry standards: CMMI, Agile / SCRUM, RUP, SWEBOK, PMBOK.

Our story

Founders of SMEDIX successfully led large distributed Software Teams for over 20 years developing and outsourcing medical software in health care (Clinical Diagnostic, drug delivery systems). We’ve seen what works and know what it takes to foster a strong and effective working relationship with our clients, their vendors and get the job done.

Our primary mission is to help our customer’s succeed and to build long-term relationships. We have the know-how and the insight on what it takes to realize Medical Software Products that meet the safety, quality and usability attributes in the medical software industry.

We can do it faster and at a lower cost. Smaller company translates to: simpler process, 
fewer project personnel and lower overhead costs that make your project run more smoothly and less expensive.

Contact us

Contact us for more information!

GET IN TOUCH

Mon-Fri: 9:00 AM to 5:00 PM

Address
6725 Mesa Ridge Road, Suite 150
San Diego, CA 92121
Call Us
+1 (858) 649-1022
+1 (619) 571-7655
Fax
+1 (858) 649-1034

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