Quality & Regulatory
The Quality and Regulatory team provides embedded expertise across the development lifecycle, shaping design decisions, reducing risk, and enabling confident, compliant delivery in global markets.
Quality and regulatory compliance, propelling projects forward
Insight guided innovation
From the earliest stages, our approach shapes design decisions, accelerates development, and helps clients deliver safer, more effective medical devices, platform technologies, and future innovations. Our specialists work side by side with multidisciplinary technical teams to ensure alignment with client goals and regulatory expectations, supported by an ISO 9001, 13485, and 14001–certified Quality Management System.
Reducing risk and enabling readiness
Our expertise can be delivered as standalone support or fully integrated into product development. We work with clients to ensure supply chain readiness, assessing supplier capability, material traceability, and documentation to meet global requirements, helping reduce risk, avoid rework, and stay aligned with approval and launch timelines. We also support certification, audit readiness, sustainability reporting, GHG disclosures, and EcoVadis submissions across QMS and EMS.
Strategy to robust delivery
Our team is embedded within project activities, working cross‑functionally to align design, development, and regulatory strategy. By partnering early with clients and technical teams, we support planning, risk management, design reviews, and verification to deliver robust outputs and anticipate regulatory expectations that shape timelines, decisions, and long‑term success.
Expert insight for reliable outcomes
We provide a central source of regulatory insight, helping clients navigate an evolving regulatory environment while delivering consistent, reliable design outputs aligned with industry best practice and ISO 13485 risk‑based quality management.
A trusted partner
Trusted by 18 of the world’s top 20 pharmaceutical companies, we provide bespoke support across device discovery, development, and evaluation in complex regulatory environments. By combining regulatory rigour with deep development expertise, we help reduce risk, support confident decision‑making, and deliver efficient, globally aligned outcomes.
Sustainability built into quality
We embed ESG principles within our quality management approach to support responsible global supply chains. This includes ISO 14001 certification, structured sustainability reporting aligned to GRI standards, CDP GHG disclosures, and participation in global initiatives such as EcoVadis, where Crux has achieved a Platinum Rating rating. Backed by independent assurance, we are a trusted partner for organisations navigating evolving ESG requirements.
Areas of expertise
Market Access Strategy
Governed Design & Development
Risk Management
Submission‑Ready Documentation
Managing Complex Compliance
Quality Systems & Compliance
“Quality and Regulatory builds confidence, reduces risk, and enables innovation. We take pride in our commitment to meeting the strict regulatory and legal requirements that govern medical devices and consumer goods. We are also driving smarter and more sustainable ways to deliver them. Our team thrives on curiosity and collaboration, and we have created an environment where compliance supports creativity.“