Software Quality & Regulatory Compliance
done properly without the consultancy bloat.
GLC helps organisations deliver high-quality, standards-compliant software in domains where reliability, safety, and regulatory adherence are critical to success.
We work with teams operating in regulated and standards-driven environments, embedding quality and compliance into everyday engineering practice rather than treating them as late-stage documentation or audit activities. Our approach ensures systems are robust in operation, defensible under review, and sustainable across their full lifecycle.
We bring deep, hands-on experience working with IEC 62304 and ISO 14971, applying these standards pragmatically as part of day-to-day software engineering. We also operate confidently within ISO 13485 quality management systems, recognising their role as the overarching framework governing software and risk management activities.
Our experiencespans medical devices, industrial and infrastructure systems, wireless and telecommunications platforms, and public-safety products. We have supported major pharmaceutical organisations and worked alongside leading international consultancies on complex, regulated programmes where technical depth, delivery rigour, and regulatory confidence are essential. Our work aligns software with international and regional standards, including IEC 62304, ISO 14971, ISO 13485, 3GPP specifications, and British and European safety standards.
How we support you
Standards-Aligned Development Processes -
We help define, assess, and improve software development processes to ensure alignment with the standards and regulatory frameworks relevant to your product and target markets.
This includes supporting new product development as well as existing systems that must be brought into compliance.
Our focus is on applying standards in a practical, engineering-led way, ensuring processes are proportionate, effective, and workable for real delivery teams.
Risk Management & Traceability ———————-
We support structured software risk management appropriate to your regulatory domain, including hazard identification, definition of risk controls, and linkage to verification activities.
We establish and maintain end-to-end traceability across requirements, architecture, design, implementation, and verification evidence. This enables clear change impact analysis, supports confident technical decision-making, and provides robust justification during review or assessment.
Verification, Validation & Evidence Generation ——-
We define verification and validation strategies that balance regulatory expectations with engineering efficiency. This includes unit, integration, system-level, and regression testing, as well as the generation of clear, auditable evidence.
Where off-the-shelf tools are insufficient or impractical, we design bespoke test frameworks tailored to the system architecture and regulatory context, ensuring verification activities are both effective and sustainable over time.
Documentation & Audit Readiness ————————
We author and review standards-aligned software documentation, including development plans, requirements, architecture and design descriptions, and verification artefacts.
We also support audit and assessment readiness by identifying compliance gaps, prioritising remediation actions, and helping teams prepare for internal audits, external assessments, customer reviews, and regulator or notified-body scrutiny.
How we work
We treat regulatory and standards requirements as engineering constraints, not paperwork obligations. Quality and compliance are considered early and continuously, influencing architecture decisions, coding practices, verification strategies, and change control processes.
By working closely with delivery teams, we help reduce late-stage risk, avoid costly rework, and enable confident progression from development through certification, deployment, and long-term maintenance.
Typical applications
Wireless and telecommunications systems aligned with 3GPP specifications
Medical device software developed under IEC 62304
Public-safety and alarm systems requiring compliance with British and European standards
Let’s work together
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