We are Human achieves ISO 13485 certification
Following a successful stage 2 audit without a single non-conformance, We are Human is proud to announce we have achieved ISO 13485:2016 certification.
Claire Roberts, our Principal Human Factors Consultant & Quality Manager, spearheaded this impressive achievement with support from Emma Holmes and Matt Curtis at Copperhead QARA/RP.
Claire shares why we pursued ISO 13485 certification.
What is an ISO 13485 certification?
ISO 13485 prioritises patient safety by ensuring consistent quality at every stage of a medical device’s lifecycle, from design and manufacturing to disposal. It assures customers and regulatory authorities of a high level of quality control and commitment to continuous improvement in the design, manufacture, and distribution of medical devices.
“Developing our QMS inline with ISO 13485 was a no-brainer for us. We have always been committed to delivering technical excellence and quality to our clients, so formalising our existing processes and gaining certification is the cherry on the cake!” – Claire Roberts, Principal HF Consultant and Quality Manager
What inspired We are Human to align with ISO 13485?
Experience: From the outset, We are Human recognised the value of ISO 13485 certification. Our team has extensive experience working within ISO 13485-certified environments, giving us first-hand insight into how structured quality management enhances efficiency, consistency, and compliance. This deep-rooted experience ensures that our work aligns seamlessly with the regulatory expectations of medical device companies.
Reputation: As a trusted Human Factors / Usability Engineering (HF/UE) consultancy supporting medical device companies in both the UK and USA, achieving ISO 13485 certification reinforces our reputation for excellence. It demonstrates that we operate to rigorous quality and safety standards, providing confidence in our ability to support regulatory submissions and meet compliance requirements.
Partnership: Many of our clients already operate within ISO 13485-certififed environments, and achieving certification was a natural step to formalise our robust documentation and quality system. This certification assures clients that our processes align with their own, making collaboration effortless and compliance more straightforward.
Compliance Advantage: With our USA presence and the FDA’s forthcoming adoption of ISO 13485 into its QMS regulation, We are Human are positioned to support medical device manufacturers navigating evolving global regulatory landscapes. Our certification underscores our commitment to delivering high-quality, compliant, and user-centred solutions that meet the needs of both regulators and end users.
How has the quality management system improved your processes?
How will this enhance your clients experience?
Our ISO 13485 certification reassures clients of our capability to support the development of innovative medical products, adhering to the highest standards of quality, safety, and compliance.
- We work collaboratively with our clients, partners, and study participants to ensure a high level of client satisfaction and project realisation
- We employ and develop the best expertise and experience in the field
- We facilitate continuous improvement through regular review and monitoring of processes and systems
- We use a risk-based approach to enable innovation whilst maintaining compliance with regulatory and quality requirements
Would you like to hear more about how we can support with your Human Factors / Usability Engineering activities?
