Services

APPLICATIONS & TECHNICAL SERVICE

Our highly-trained team of Application Specialists, Technical Service Managers, and Field Service Managers prepare you for success with all the GSD products and instruments. Beyond simply providing technical customer support over the phone, the Technical Service team works together to provide our customers with installation services, training services, hardware support, software and LIS support, and lab workflow analysis. Each member of our team is thoroughly cross-trained on engineering principles and biochemical assay application work to provide our customers with comprehensive support at any time. We provide professional and personal support for each of our laboratories and their technicians.

  • Being on a team with so many committed and talented people is amazing!

    Amanda Applications Specialist
  • We encourage open feedback from our customers. As a full-solution company, we turn that feedback into tangible changes in our software and products.  Being out in the field with customers, we get a first-hand understanding of the challenges that they face, and are able to better support them.

    Allison Technical Services Manager
  • It is incredibly rewarding to work with dedicated individuals to provide the best customer service in the industry!

    Juliana Technical Account Manager

NATIONWIDE TECH SUPPORT & SALES

Customers experience different government reimbursements and market pressures based on geographic region, but GSD’s sales and support teams understand these variances and provide the appropriate support and information to add value. Our team of sales and technical support personnel are strategically located across the country to effectively support clients in every state. Laboratories will experience superior customer service any time of day or night.

SERVICE & SUPPORT BENEFITS

  • Product Experts
  • Fully-operational Evaluation in Your Lab
  • On-site Training
  • Single Point of Contact
  • Ongoing Customer Support, 24 x 7

ASSAY DEVELOPMENT

GSD has extensive knowledge of our customers and many years of industry experience. We assess the needs of customers in different markets and develop solutions to meet those needs. Our team of scientists provides solutions to market needs.

Our team’s skill in navigating U.S. and international regulatory requirements allows us to swiftly move newly developed products through clearance processes. We have experience obtaining U.S. product approval through the FDA, as well as CE approval and product registrations internationally.

Gold Standard Engineering

GSD’s engineering division, Gold Standard Engineering, possesses capabilities for both instrument hardware and software development. Many companies are limited to either hardware or biologics, but we develop innovative products for both. We test and build our own designs, and also work with partners from  throughout the entire design cycle from prototyping to production.

HARDWARE DEVELOPMENT

GSD develops new platforms to automate cutting-edge technologies in the clinical sphere. Our team focuses on developing engineering designs that optimize the automation of laboratory testing.

We have streamlined the process of moving new instrumentation from proof of concept to prototype to final product. Our engineering and R&D teams are not only able to implement innovative solutions, but also provide sustained engineering for ongoing product improvement.

SOFTWARE DEVELOPMENT

New software applications that complement our instrument platforms are developed by our expert software engineering group to be innovative and effective, but also to provide a clean user-friendly interface experience.

GSD designs and implements the software for our automated platforms to meet the specific needs of its customers. Our Software Development eam works closely with our Technical Services team to fully understand the goals and requirements of our customers.

GSD understands the requirements for developing products that comply with the appropriate guidelines to meet regulatory standards. Our structured approach to design and development allows us to work quickly, efficiently, and to meet the design requirements necessary.

PROPRIETARY INSTRUMENT MANUFACTURER

GSD designs and manufacturers a number of proprietary instruments for the clinical diagnostics market, including the ThunderBolt, AIX1000, and The BOLT.

  • Advanced technologies for onsite design, development, quality, and manufacturing of diagnostic instrumentation to meet customer needs
  • Flexible and scalable production to meet customer sales demands
  • Continuous manufacturing and design process improvements throughout product life-cycles
  • Integrated validation, manufacturing, and quality control testing teams resulting in efficient and effective manufacturing and engineering solutions
  • Advanced design control and configuration management systems resulting in the highest level product reliability and quality control

ON SITE ASSEMBLY OF ALL FINISHED GOODS

Each instrument we produce is assembled in the USA at our manufacturing facility in Davis, California. From sub-assembly to finished good, burn-in and quality control testing, all steps of instrument production are completed in house by a dedicated team of engineers, technicians, and production specialists.

CERTIFIED PROCESSES AND FACILITIES

GSD is ISO certfied, GMP compliant, and Health Canada approved. Our detail-oriented regulatory and quality teams carefully monitor every step of our instrument manufacturing and quality control processes, ensuring that every instrument meets or exceeds industry standards for quality assurance.

U.S. SALES AND MARKETING EXPERTS

For more than 10 years, GSD has served many diagnostic markets, including physician-owned laboratories, large and small hospitals, and reference laboratories. Our broad menu of assays offers the laboratory a range of choices to improve efficiency, increase revenue or expand their test offering.

EXTENSIVE CONTACT BASE IN THE U.S. CLINICAL LAB MARKET

With clients in all segments of the clinical diagnostic market, our invaluable insider market knowledge enables us to reach virtually any potential customer. GSD’s technical and sales teams have relationships with key decisions makers in every market. We also have extensive market information regarding Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs). We also leverage distribution channels to expedite access to valuable accounts.

PARTNER PRODUCT CLEARANCE

Our experience in successful product clearance makes us the partner of choice for manufacturers seeking FDA clearance for their products. Our expertise with U.S. FDA and FDA 510(k) clearance encompasses all aspects of the approval process, including assay requirements, predicate devices, IRB, clinical trial study design, submission documentation and FDA communication. We successfully combine customer needs with product clearance, to bring the best products from our partners to the U.S. market.

FDA & REGULATORY EXPERIENCE

As an ISO certified company with a strong Quality system and Regulatory Affairs department, we can effectively navigate the maze of CLIA and FDA regulations. From filing for a new product to assisting end-users with in-lab validation requirements, our in-house quality and regulatory teams have years of experience.