With more than thirty years of experience we know a thing or two about computer aided design and engineering. We advise companies on the latest best practice approaches, technologies, off-the-shelf, and customized solutions. Our consultants have years of hands-on experience as drafters, designers, architects, and application engineers on projects spanning many industries. They share a passion for great design and efficiency. We don’t just go by what the vendors tell us. We listen to you, your needs, and help you optimize your workflows with the latest solutions from around the world.
Our services can be tailored to your needs and can be conducted on-site or online. For companies in highly regulated industries, we will adapt our engagements to your quality system, including for medical devices, military, aerospace, or intelligence. We have extensive working knowledge of mHealth, EHR, HIPAA, ISO 9001:2008/15, ISO 90003:2004, ISO 15189: 2003, GMP, GAMP5, ICD-9, ICD10, SNOMED-CT, MDDS, 21 CFR Part 11, DIACAP, and DoDD.
In addition to our consulting services, we offer a broad selection of affordable desktop, mobile, and cloud-based solutions for innovation and design management in BIM/AEC, construction, civil, road, landscape, sheet metal, and mechanical design, as well solutions to meet regulatory requirements in medical devices, pharma, aerospace, energy, oil and gas.
Process & Design Control
Let us help you become more agile and efficient, while maintaining compliance with your industry’s regulatory requirements. Our consultants can adapt your current processes or a recommend contemporary best practice approach. We have several cloud based solutions for secure intra- and inter-company document and design control. They tell you exactly who reviewed, annotated, and signed off on what, when, and why. The systems can handle large CAD files and all related project documents with customizable workflows, role based or named access, document version history, and detailed audit trails. With a unified project view that can include external customers, designers, architects, engineers, contract manufacturers, and suppliers, they reduce project risks and streamlines processes, especially in highly regulated environments such as medical devices, pharma, aerospace, and energy, oil & gas.
Custom Software Development
If an add-on solution does not exist, let us develop it for you. We have access to the best CAD/CAE/BIM/3D software development talent from the around the world and use a hybrid agile methodology that is in compliance with your industry’s regulations. A proper architecture is critical in defining how processes flow. We assure that a solution can meet your functionality, performance, scalability, security, and quality requirements. We will recommend commercial and open-source foundations wherever they make sense, maximizing value at the lowest possible cost. We continuously evaluate new platforms and technologies in search of innovative functionality, design flexibility, performance, stability, and more than anything, great value. We have experience with ISO 9001:2008, ISO 13485, QSR 21 CFR 820, IEC 62366 (usability/Human factors), IEC 62304, IEC 60601, IEC 81001 (software), and IEC 62304, IEC 81001 (SDLC for safety and cyber security).