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Our Services

Partner with SMEDIX to 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.

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.

Our Products

Solutions to enhance your medical device

About Us

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, Medical Devices). We’ve seen what works and know what it takes to foster a strong and effective working relationship with our clients to get the job done.

Our primary mission is to help our customers succeed and to build long-term relationships. We have the IVD experience and the insight to bring Medical Software Products to market 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.

Leadership Team

Fayez Sweiss
President & CEO

Fayez Sweiss founded SMEDIX in 2013 and holds the role of Founder and CEO. Previously, Fayez served as the Director of Software Development for Gen-Probe Inc. (Currently Hologic) for 10 years where he led software development efforts for multiple medical diagnostic instruments including integration of numerous Assays commercialized 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 several new medical devices including infusion systems, cardiac monitors and various applications for drug delivery and medication management systems. 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.

Shane Dultz Ph.D
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 developing 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.

 
Brad Tieman M.B.A.
VP Commercial Operations & Business Development

Brad joined SMEDIX in 2019 to serve as Vice President, Commercial Operations and Business Development. Brad heads the development of the company’s product and commercial strategy, managing the company’s product portfolio and business needs of our key partners within the in-vitro diagnostics (IVD) industry. Brad has held senior leadership roles in product development, field service, marketing, sales, business development with Gen-Probe, Hologic and GenMark Diagnostics with a focus on bringing innovative customer-focused technologies to the global market over the past two decades. Brad is a patent holder and earned a B.S.E. in Chemical and Biochemical Engineering from Michigan State University and an M.B.A. from University of Redlands Business School.

 
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 was a software test lead for Molecular Diagnostic Instruments. He was promoted to lead testing efforts for the Remote Diagnostics and Serviceability software of the Diagnostic Instruments. 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 solution monitoring 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) & GM SMEDIX Romania

Florin joined SMEDIX in 2015 and is the VP of Software Engineering (EU) and General Manager of SMEDIX Romania. His strong leadership, proven track record and diversity of technology stacks enabled him to effectively lead various projects for SMEDIX. 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)

Adrian joined SMEDIX in 2017 as the Director of Software Development & Operations in Romania. Adrian has a distinguished career and is 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 is constantly looking to improve the quality of customer deliverables and productivity of his engineering team. Adrian is a certified expert in the software development process frameworks and industry standards: CMMI, Agile / SCRUM, RUP, SWEBOK, PMBOK.

 

Contact us

Contact us for more information!

US HEADQUARTERS

Mon-Fri: 9:00 AM to 5:00 PM (PST/PDT)

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

+1 (858) 246-6055

Fax
+1 (858) 246-6062
EMEA HEADQUARTERS

Mon-Fri: 9:00 AM to 5:00 PM (GMT+3)

Address
Strada Tăietura Turcului 47
Cluj-Napoca 400000
Romania

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