We Document,
You Innovate
Our Services
Software Engineering and Documentation
Documentation of software systems, and software components by documenting the system requirements, software requirements, software architecture and software designs. Software engineering principles and techniques are used to develop documents for 510(k) submissions. The software documentation makes the biggest portion of the DHF.
Software Risk Management
Software risk management is performed per ISO 14971 (and TR 24971) to identify risks related to software and software control measures. Risk Management process is documented to become a part of the DHF. Our experts were trained by industry expert Nancy Leveson of MIT.
Software Validation and Verification
Verification of software requires careful planning and strategizing based on the software language, complexity of source code and risk factors. Documentation of the software verification activities is equally important for 510(k) submissions. Bioscience Pro develops plans and test protocols for all software verification levels such as software system, integration and unit.
Cybersecurity Risk Management
Cybersecurity Risk Management should be defined as a separate process. The Cybersecurity Risk Management approach as a Threat, Vulnerability or Asset based analysis is defined. The process and its implementation is compliant with AAMI TIR 57.
ISO 62304 Training and Implementation
Online and in-person training is provided to help establish a sound Software Quality System based on ISO 62304. The training is given by experts with a background in software development. NOTE: ISO 62304 training should be provided by qualified personnel with Software Development experience.
We Integrate With Your Ecosystem
Our staff forges with your team and processes to take care of the regulatory and quality documentation which often saps a high-performing group's energy.