FDA Software Quality Assurance – 510(k) Readiness

FDA Quality Systems Development

BAT works with their clients to build effective software quality systems that meet the 21 CFR Part 820 standards established by the FDA for medical device manufacturers. We also assist our clients by providing analysis of a clients existing quality system and provide change recommendation to help increase the likelihood of a success FDA audit. Our role in the development of quality systems varies based on our customers needs. We have helped early-stage medical device companies to design and create their software quality system and other cases we’ve worked with our clients to enhance their existing quality system for the needs of software.

Specification Development

Software specifications are the foundation for a robust and complete product. A complete and clearly written software specification will help to ensures that a product will meet: customer expectations, product marketing goals, and performance metrics. Design specifications server many purposes most importantly they provide a blueprint for the architecture and design of software. BAT knows how to develop requirements specifications and design specifications. We have performed these services for medical device and digital equipment companies alike.

  • Software Requirements Specification
  • Software Architecture Specification
  • Software Design Specification

Standard Operating Procedure (SOP) Creation

The 21 CFR Part 820 states that each manufactures shall establish a standard set of operating procedures or ‘SOP’s to define the activities related to the design and development of software intended to used in a medical device. The development of effective SOPs is critical step to establishing a compliant software quality system. The software development SOP is intended to provide the members of the software development team with a set of procedures:

  • Configuration Management SOP
  • Verification and Validation SOP
  • Risk Management SOP
  • Design Reviews SOP
  • Software Development SOP
  • Software Tool Validation SOP
  • Code Inspection SOP
  • Defect Tracking

Software Plan Development

Software plans are created for each individual product being developed. While the SOPs define ‘how’ the activities will be conducted during the product development life-cycle, software plans should define the ‘what’ activities will occur during the product development life-cycle. The plans typically identify the task, team members, and work output. BAT has developed software pans for class I, class II, and class III medical device companies. Our experience developing software plans includes:

  • Software Project Plan
  • Software Development Plan
  • Configuration Management Plan
  • Verification and Validation Plan

Hazard Analysis

Hazard analysis and risk management are 2 very important aspects of any quality system whether intended for the medical device industry or the nuclear industry. BAT has participated in the hazard analysis of class II and class II medical devices include FMEA and FTA.

  • Failure Mode and Effective Analysis (FMEA)
  • Fault Tree Analysis (FTA)

Through our network of partners, BAT offers training in both FMEA and FTA. For more information on our training see http://www.swqual.com/consulting/fda/medicaltraining.html