Product Overview
Software Design and Development
Since 1997, Apartis Information Management Inc. has specialized in total lifecycle custom software development services for healthcare and life sciences. We help our customers optimize laboratory workflows with state-of-the-art software architecture and design. Our complete lifecycle services include technical consultation, requirements development, risk management, engineering, testing, documentation, compliance support and maintenance.
Our customer portfolio includes many multinational diagnostic, pharmaceutical, assay and instrumentation (laboratory automation) manufacturers as well as a healthy mix of individual laboratories and novel technology startups. Apartis’ OEM software is used worldwide and is designed to support our customers’ corporate identities as well multiple languages.
Because many of our customers require adherence to strict FDA guidelines for software development and medical device quality systems, from our foundation >20 years ago, the Apartis quality system is based on the FDA’s general principles of software validation. We support the following design and development guidelines:
• 21 CFR Part 820 (quality system regulations)
• 21 CFR Part 11 (electronic records & signatures)
• ISO 62304 (software lifecycle process for medical device software)
• ISO 13485 (quality management system for medical devices)
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