Software Quality Consulting
Software Quality Consulting, founded in 1997 by Steven R. Rakitin, offers expert consulting, training, and auditing services for the Medical Device, BioTech, Pharma, Nuclear Power, Transportation, and Mission-Critical industries. With over 45 years of experience in software engineering and over 35 years in the regulated industries, the company aims to help clients design and develop safe, compliant, and high-quality software solutions efficiently. Their approach emphasizes building trust, understanding client needs, and fostering organizational change to improve product quality, reliability, and predictability.
Industries
Nr. of Employees
small (1-50)
Software Quality Consulting
Products
Software Verification and Validation for Practitioners and Managers (book)
Technical book covering software verification and validation practices for people working in regulated industries; includes methods and guidance for V&V activities.
Software Verification and Validation for Practitioners and Managers (book)
Technical book covering software verification and validation practices for people working in regulated industries; includes methods and guidance for V&V activities.
Services
Advisory services to interpret and apply FDA, EU, and international standards and guidance to medical device software and quality systems.
Public courses, on-site tailored workshops, and short seminars on software development, V&V, risk management, and regulatory requirements for device software.
Planned compliance audits, supplier surveys, and gap analyses with detailed reports and regulatory traceability for medical, nuclear, transportation, and mission-critical projects.
Development and verification services for embedded, imaging, and mission/safety-critical software, including test planning, execution, and documentation.
Support for CGD plans, verification/validation, hazard analyses, and audits to qualify commercial digital equipment for nuclear safety applications.
Advisory services to interpret and apply FDA, EU, and international standards and guidance to medical device software and quality systems.
Public courses, on-site tailored workshops, and short seminars on software development, V&V, risk management, and regulatory requirements for device software.
Planned compliance audits, supplier surveys, and gap analyses with detailed reports and regulatory traceability for medical, nuclear, transportation, and mission-critical projects.
Development and verification services for embedded, imaging, and mission/safety-critical software, including test planning, execution, and documentation.
Support for CGD plans, verification/validation, hazard analyses, and audits to qualify commercial digital equipment for nuclear safety applications.
Expertise Areas
- Medical device software development
- Regulatory compliance and submission support
- Software verification and validation
- Quality Management Systems and ISO 13485
Key Technologies
- Embedded real-time systems
- Software verification and validation methods
- Fault tree analysis
- Failure Modes and Effects Analysis (FMEA)
News & Updates
Examples of past consulting engagements
The company has provided various consulting services including software process review, risk management, quality system development, and audits for clients in medical devices, biotech, pharma, nuclear, transportation, and other industries.
An article by Steven R. Rakitin discussing the importance of collaboration in networked medical devices for safety.
An article by Steven R. Rakitin on handling defective software in medical devices.
An article on project estimation and scheduling.
Examples of past consulting engagements
The company has provided various consulting services including software process review, risk management, quality system development, and audits for clients in medical devices, biotech, pharma, nuclear, transportation, and other industries.
An article by Steven R. Rakitin discussing the importance of collaboration in networked medical devices for safety.
An article by Steven R. Rakitin on handling defective software in medical devices.
An article on project estimation and scheduling.