Quality and Regulation in Healthcare Engineering, A Conversation with David Williams

We recently sat down with David Williams, our Head of Quality & Regulatory, to talk about how quality is embedded across the business, how expectations are shifting in a global context and what the future looks like for quality and regulatory practice at Crux. In the Q&A below, David shares his perspective on how this function continues to evolve and why it remains central to the work we deliver.

How do you see regulation acting as an enabler of product development rather than a barrier?

Regulation is only a roadblock when it is poorly understood and implemented in a rigid fashion without accounting for important aspects such as risk-based prioritisation and task-focussed process optimisation.  When processes are prioritised and controlled based on the scope of the activities being undertaken by an organisation it can actively accelerate innovation. Clearly defined regulatory strategies and quality processes provide structure and predictability, giving innovators the confidence to move quickly while ensuring compliance. When project managers and teams align their activities with regulatory goals from the outset, they reduce the risk of late-stage problem-solving and wasted effort. Enabling and empowering quality and regulatory experts within an organisation helps embed compliance into strategic decision making rather than shoehorning it in at a later stage. This proactive approach not only saves time but also strengthens credibility with regulators and stakeholders.

Crucially, regulations are not intended to create unnecessary obstacles; they exist to enhance device safety, performance and standardise practices across the medical and healthcare industry.  Just as innovation is perceived as an essential aspect of the future of human health and wellbeing, regulations are the bedrock upon which these innovations will stand when they are being transformed into marketable products for patient benefit.

The US environment is often described as more dynamic, what opportunities does this bring for clients and projects?

The US regulatory environment is dynamic due to the definition of distinct pathways for the development and market approval of new products.  Risk-based controls over preclinical and clinical research are aimed at facilitating patient benefits without undermining safety throughout the pre-market lifecycle of a new device. This approach brings clear advantages for device and pharmaceutical companies, which we seek to leverage in our quality processes. The FDA’s emphasis on a risk-based rationale allows for proportional oversight, creating flexibility for lower-risk devices and clinical activities such as human factors and usability studies. This approach enables companies to generate meaningful evidence of safety and performance without being overburdened by unnecessary requirements.

Review boards are a vital piece of the puzzle, adding a crucial layer of structured oversight, providing assurance while keeping pathways efficient.

By combining regulatory agility with a clear focus on risk, the US environment allows development timelines to accelerate, without sacrificing compliance or rigor. Our operations in the US regulatory landscape, meeting national and international standards, mean that clients benefit from both speed and quality in their projects.

What makes clients value our international reach and regulatory expertise?

Clients value our approach to regulatory requirements and quality management, both the knowledge that we bring but also the willingness to develop and build processes around new challenges and opportunities in an ever-changing landscape. Operating across multiple regions means we understand the nuances of compliance requirements and the necessity of adapting processes to meet the expectations of regulators and of clients. This reach allows us to bridge frameworks effectively, ensuring clients remain compliant no matter where they operate. Furthermore, we ensure that client projects are delivered with confidence, even when regulatory landscapes differ, by embedding risk-based thinking and quality management principles into our approach.

Quality runs through every part of the business. How do you help ensure it stays front and centre in daily decision-making?

Quality is most effective when it’s not confined to a single department but embedded throughout the entire business. We achieve this by integrating quality principles into all our processes; from project planning through to supplier management and project delivery. This ensures quality is not an afterthought but a driver of decision-making at every stage.

Training and awareness within the team is also essential so that all personnel are on the same page when it comes to the importance of compliance, not only to ensure requirements are met but also to improve processes in the future. The Crux Quality team are focussed on equipping team members with a clear understanding of regulations, internal quality processes and best practices, as defined within our quality management system so that we build a culture where every individual sees themselves as accountable for quality outcomes. Shared values, reinforced through consistent messaging and leadership commitment, make these principles part of daily practice.

Our management review meetings bring senior leaders together. What makes these sessions important for maintaining integrity across the company?

Our quarterly management review meetings are a cornerstone of how we maintain integrity and accountability across the company and ensure continued alignment to the requirements of our quality management system. These sessions bring senior leaders (i.e. top management) together to evaluate process performance against our quality objectives, review audit outcomes, assess risk trends, and ensure our Quality Management System (QMS) remains both compliant and effective.  These sessions are also an opportunity to assess upcoming changes in the regulatory landscape and discuss what opportunities these present and where risks may be introduced if actions aren’t taken.

Beyond compliance, the meetings provide strategic foresight. They create space to step back from routine operations and reflect on what’s working, where improvements are needed, and how regulatory trends or market shifts might impact future priorities. The structured nature of management reviews ensures that decisions are data-driven and aligned with a long-term quality strategy.

Equally important, these sessions reinforce a culture of shared responsibility through aligning corporate leadership around quality goals and continuous improvement.

We hold several certifications and accreditations. Which stand out most to you, and how do they help build trust with clients?

Our Quality Management System (QMS) is integrated to deliver compliance across ISO 9001, 13485 and 14001.  This means that every project at Crux is subject to a series of defined processes that ensure consistency, quality and reliability for our clients.  ISO 9001 underpins our Quality Management System, ensuring consistency, traceability, and continual improvement across all operations. ISO 13485 adds the rigor needed for medical device and healthcare-related work, aligning us with global expectations for device design and development.

Furthermore, as environmental management and sustainability is also embedded into our QMS, we can efficiently demonstrate compliance to meet the emerging needs for verification of sustainable development and ethical business practices. Certification to ISO 14001 reflects our proactive approach to environmental responsibility, integrating sustainability into project planning and daily operations. Meanwhile, our recent EcoVadis Platinum rating highlights our broader commitment to ethical business practices, social responsibility, and transparent governance.

For clients, these accreditations offer the assurance that we meet internationally recognised standards while maintaining the agility to tailor solutions to project-specific needs. We are also able to meet the highest standards of sustainability to support our client’s supply chain requirements and targets for sustainable procurement and sustainable development.

Sustainability is increasingly central to quality. What role does your team play, and what can readers look forward to in the end-of-year update?

Sustainability is no longer an optional add-on for companies such as Crux, with international regulations creating greater pressures on our clients to meet environmental and sustainability targets we have made this an integral part of our QMS and a clear element of project quality. Internally, collaborative teamwork is focussed on embedding sustainable thinking into every aspect of compliance and operations. Through alignment with ISO 14001 and the clear requirements of reporting frameworks such as CDP, GRI, UNGC and EcoVadis, we continually assess our environmental impact and seek to develop new ways to address key topics and issues that relate to our operations.

As part of our commitment to transparency, we publish our sustainability policy on the website along with our annual sustainability report. These documents are the basis on which we are assessed for compliance with the requirements of the various reporting frameworks and provide assurance to our clients that we are a trustworthy and ethical supplier.

Looking ahead, what areas of quality and regulatory compliance do you think will matter most to clients in the coming years?

The future for Crux, in terms of quality and regulatory compliance, is being shaped by the nature of the activities we are getting involved in with our clients.  In some instances, this looks like developing agile pathways for regulatory compliance in clinical research and human factors studies (through both our UK and US offices). The opportunities to develop new technologies at the interfaces of regulations is also a great opportunity for us to expand our horizons and apply our expertise to increasingly demanding projects – ranging from drug-device combination products, to programmable electrical medical systems, and beyond.

What will matter most to clients is the ability to manoeuvre and adapt to a changing regulatory landscape while maintaining delivery timelines without undermining established processes and without bypassing clearly defined regulatory requirements.  In our experience, clients look for partners who not only meet regulatory requirements but also demonstrate transparency, accountability, and responsibility throughout their operations. We can achieve this through clearly defined quality processes, open and well-informed communication with our clients (supported by our dedicated project management and quality teams) and by providing solutions rather than obstacles to progressing with innovative opportunities for research and development.