V-Shell Experts have assisted organizations in assuring critical software in various sectors such as Avionics, Telecommunication systems, Medical devices, Transportation and Government complex embedded systems.
V-Shell provides practical consulting for Software Quality Assurance and Software Validation and Verification.
We have expertise in many international standards, regulations and best practices including: ISO 9000,
ISO9001, ISO13485, ISO14971, IEC62304, FDA Quality System Regulation (QSR),
21 CFR part 11, CMMI, 6-Sigma (DMAIC)
We interpret and implement standards requirements to support software related medical devices products to conform to regulation requirements.
If you want to distribute your software-related medical devices in the United States, Canada, Europe, and other places around the globe, we can help you with FDA Quality System Regulation (QSR) and ISO compliance.
We cover all the software activities, phases during life-cycle as required by FDA and CE:
- software design
- software implementation/coding
- software reviews (Requirements, Design, Code)
- software testing (Unit, Integration, System)
- software configuration management (SCM)
- defect tracking and management
- software releases
- software project management
- software quality assurance
- software requirements
Supporting and Coaching Software Development
- Definition of Software Quality Policy including software development life cycle procedures, templates and tools
- Coaching and training of Software teams
- Producing required documents: SRS, SDS, STP
- Preparing Quality Manuals
- Writing SOPs
- Defining quality plans and goals including clear metrics
- Training of employees on the quality system, ISO standards and FDA QSR
- Producing Validation Documentation: STP, STD, STR, IQ, OQ, PQ
- Creating related SOPs, Traceability Matrices, Audit and review
- Developing Software Validation Master Plan and Policy
- Supporting Test Execution (Manual / Automated)
- Performing FMEA , FMECA
- Performing Root Cause Analysis using techniques such as Fish Bone, brainstorming
- Assessing compliance required standards
- Gap analysis and Corrective Action Plan - CAPA
- SQA monitoring
- Internal software audits
- Performing Management Reviews and Internal Audits
- Establishing improvement plans according to audits results
- Sub-Contractor and Software Vendor Site Audits
Risks Management
- Performing risk analysis and management according to ISO14791
- Developing a comprehensive Risk Management process integrated with activities
such as CAPA, V&V, FMEA and FMECA
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