This involves analysing the relevant regulations and standards that apply to either a product or service. We work with clients to identify the appropriate regulatory requirements and assess the level of regulatory risk associated with the product or service.
Once the regulatory requirements have been identified, we can help clients to develop a regulatory plan. This plan will outline the regulatory pathway for the product or service, including the types of regulatory submissions that will be required and the timelines for each submission.
As regulations change and evolve, our team will update the regulatory strategy to ensure that the products remain compliant. This may involve updating the regulatory plan, preparing new submissions, or making changes to the product to ensure ongoing compliance.
After the product has been approved for market, our team can provide ongoing regulatory compliance support. This involves ensuring that the product continues to comply with regulatory requirements, including ongoing monitoring and reporting of adverse events.
Subject Leader
Head of Regulatory
and Compliance
We’re experienced in conducting both formative and summative usability studies.
The purpose of a usability study is a research method used to evaluate the user experience (UX) of a product, system, or service. The goal of a usability study is to understand how well users can perform specific tasks and accomplish their goals using the product, and to support regulatory approval submissions.
“My role at Lucid is Quality Control Technician, where my responsibilities include ensuring that all our medical device products strictly adhere to the relevant standards.
My past experience includes both wet lab work and data analysis, with a strong focus on microbiology, molecular biology, genetics, and bioinformatics.
With my background in both physical products and software testing, I am responsible for planning, executing, and documenting the necessary tests to validate our products’ performance and reliability.”
“I specialise in regulatory strategy and compliance for medical devices, I navigate complex regulations, including UK MDR, EU MDR, and FDA guidelines. My expertise extends to implementing ISO 13485 quality management system audits and ensuring rigorous adherence.
Risk management in accordance with ISO 14971 is a key aspect of my work, as I diligently assess and mitigate potential risks associated with medical devices. I am well-versed in usability engineering practices outlined by IEC 62366-1, ensuring that devices are designed with the end-users in mind.
Post-market surveillance is a priority, with ongoing monitoring of product performance and prompt issue resolution. I liaise with certifying and notified bodies to facilitate smooth certification processes.
I am also well-versed in NHS standards and requirements, such as DTAC, aligning products with healthcare system needs. With a pragmatic and empathetic approach, I advocate for balanced and user-centric medical device regulation and usability engineering practices, ensuring optimal outcomes for both stakeholders and end-users.”
My Expertise
User experience research
Usability studies
Human Factors
Regulatory compliance
Regulatory strategy support
Instructions for use
“As the director of innovation, I excel in various aspects of project execution and product development. With a strong focus on project direction and management, I provide strategic guidance, establish priorities, and monitor progress to ensure successful outcomes.
My expertise in industrial design and usability allows me to create innovative and user-centric product designs, incorporating feedback and conducting usability assessments. Through prototyping and rigorous testing, I iterate designs to optimize functionality, durability, and safety. Furthermore, my knowledge of design for manufacture enables me to develop cost-effective and efficient manufacturing processes. By seamlessly integrating these skills, I ensure the seamless execution of projects and deliver high-quality, user-friendly, and manufacturable products.”
My Expertise
Idea generation and concept development
Industrial design
Usability studies
Prototype and test
Design for manufacture
In house manufacture
“As the leader of a multidisciplinary team at Lucid, I supervise usability, compliance, engineering, design, and manufacturing specialists who work together to create innovative products and digital interactions for health, personal care, and scientific markets. At Lucid, our focus is on developing exceptional product experiences that comply with complex regulatory constraints, leveraging our accreditation to ISO 13485 for medical device design and manufacturing.
With over 30 years of experience in product development, I have accumulated a broad skill set, including an MBA degree, Chartered Engineer certification, and membership in the Institute of Engineering Designers. I have also served as a board member of the British Industrial Design Association, further showcasing my expertise in the field. Together with my skilled team at
Lucid, we are committed to creating innovative, compliant, and user-centric products that make a positive impact in various markets.”
My Expertise
Regulatory compliance
Regulatory strategy support
“As an experienced Creative Director with over 25 years experience in developing diverse products across Medical, Wellness, Industrial, and Consumer sectors. In my role, I hold significant company responsibilities as a Project Manager and Team Coordinator.
With a focus on highly regulated products, I lead comprehensive Research and Development from concept to manufacturing. Drawing on multiple disciplines, I integrate ideation, Industrial Design development, and prototyping for successful production. I ensure seamless collaboration with manufacturers to achieve optimal product quality.
Leveraging my extensive experience and diverse skill set, I contribute to project success and enable the launch of exceptional products.”
My Expertise
User experience research
Idea generation and concept development
User experience design
Usability studies
Brand and pack design
Instructions for use
Design for manufacture
In house manufacture
“I specialize in Research and Development, sourcing components, designing, testing, and manufacturing processes for innovative and high-quality products. With expertise in electronics hardware circuits, I create intricate designs and simulations using advanced software. I produce meticulous specifications, technical drawings, and comprehensive documentation. Conducting prototype testing using state-of-the-art equipment, including an in-house EMC chamber, ensures optimal performance and compliance. By establishing partnerships with leading suppliers and distributors like Arrow, Avnet, ST, NXP, I access the latest components and solutions.
I am responsible for ensuring EMC compliance throughout the product development process, conducting thorough testing. With a focus on R&D, precise design, and expertise in EMC compliance, I contribute to the development products that meet the highest standards and regulatory requirements.”
My Expertise
Electronic hardware design
Prototype and test
Design for manufacture
In house manufacture
“My day-to-day life involves researching, designing and prototyping products and user interfaces.
Collaborating closely with a diverse team of software developers, design engineers, clinicians, and patients, my objective is to create intuitive and inclusive designs that cater to the needs of all users.
One of the most rewarding aspects of my job is witnessing first-hand how our efforts positively impact people’s health and wellbeing. From developing pelvic floor training aids and enuresis therapies to transcranial magnetic stimulation therapy systems and beyond, every project we undertake is rooted in the desire to make a tangible difference in people’s lives.”
My Expertise
User experience research
Idea generation and concept development
User experience design
User interface design
Usability studies
Brand and pack design
Instructions for use
“As a Software Engineer at Lucid, I am deeply involved in the development of software solutions. My role encompasses the design and implementation of both embedded and application software, catering to a diverse range of products. One of our key areas of focus involves the creation of wireless-controlled devices, seamlessly interfaced through Android and Windows applications. Each project typically kicks off with a meticulous requirement gathering process, followed by the development of software that precisely aligns with the specifications.
Through rigorous testing and continuous improvement efforts, we strive to enhance the quality and performance of our products wherever feasible. By ensuring the seamless integration of software components, I contribute to the delivery of innovative and user-friendly solutions that meet the needs and expectations of our clients.”
My Expertise
Software development
Data management
Embedded Software
“I am responsible for mechanical design from concept through to prototyping, verification, testing and manufacture. I bring 10 years medical device development experience to the Lucid team. I translate client briefs into commercially feasible products.
Working with an in-house cross-functional team allows me to rapidly deliver design solutions that balance stakeholder requirements, technical constraints and regulatory inputs with user needs.
Verification and testing play a critical role in my work, as I meticulously assess and validate designs for functionality, performance, and durability.
By leveraging my expertise in Mechanical Design, project management, and ISO 13485 documentation, I contribute to the development of high-quality products that meet regulatory standards and exceed customer expectations.”
My Expertise
Idea generation and concept development
Industrial design
Prototype and test
Design for manufacture
In house manufacture
Brand and pack design
“I am a Sustainability Specialist with 7+ years of experience in Sustainability Assessment, Life Cycle Assessment, and product-based carbon accounting. My focus is ensuring Sustainable Development in medical devices and healthcare industry.
My work is delivering Sustainability Assessment for medical devices, healthcare industry, and relevant areas. This includes strategy planning aligned with Net Zero Target and Sustainable Development Goals (SDGs), delivering carbon portfolio for companies and organizations, supporting suppliers to qualify Sustainable Supplier Assessment, and supporting service
to improve product and business’s sustainability through material selections.”
My Expertise
Net zero strategies
Life cycle analysis
“My role encompasses a wide range of responsibilities related to manufacturing and prototyping medical devices. I oversee the entire process, from initial concept to final production, ensuring adherence to quality standards and regulatory requirements. Through meticulous device testing and data analysis, I assess performance, identify areas for improvement, and optimize functionality and safety.
Additionally, I play a vital role in implementing design changes using computer-aided design (CAD) software, effectively translating conceptual modifications into tangible product enhancements. Leveraging engineering analysis techniques such as finite element analysis (FEA) and system modelling, I conduct thorough assessments to validate and optimize device performance and durability. By seamlessly integrating these skills, I contribute to the development of medical devices that meet the highest standards of quality and effectiveness.”
My Expertise
Idea generation and concept development
Industrial design
Prototype and test
Design for manufacture
In house manufacture
“I spend most of my time busy in the workshop where I am well-versed in utilizing a range of advanced production methods, including vacuum casting, 3D printing, silicone moulding and laser cutting, to bring these ideas to life. This enables me to create prototypes and manufacture parts efficiently, even for low-volume production.
By leveraging these techniques, I contribute to the realization of functional and visually captivating prototypes. These prototypes not only accurately represent the design intent but also pave the way for successful production, ensuring that the final products meet the desired specifications and objectives.”
My Expertise
Industrial design
Prototype and test
Design for manufacture
In house manufacture
Instructions for use