Innovating better life
Yallow is an ISO 13485 certified design & development partner specialized in medical and health technology. We are passionate about developing products and services that really mean something and make a difference. Together with our clients, we improve the future.
We are dedicated and purpose driven specialists and a trusted partner in medical and health innovation. We provide services within design & development and quality & regulatory support. Yallow is a unique fusion of a design and regulatory agency. Let’s innovate better life!
ISO 13485 CERTIFIED AGENCY
Medical development, regulatory & quality support according to internationally recognized standards
Design & Development
Our Design & Development team is home to engineers and industrial designers. Together, we are a multi-disciplinary and high-performing team of experts. We help our clients to realize new and engaging experiences, solutions, products, and services.
We offer end-to-end expertise and capacity for developing breathtaking, smart, connected, and future-proof products and services in medical and health technology. Our development processes are compliant with ISO 13485 which of course makes us a trusted and reliable partner.
We assist our clients from the initial idea and concept development, through prototyping, detailed design, and production, to realized product and market introduction. Always with creativity, commitment, and control.
We work with innovation and product development of advanced medical products, aids, surgical equipment, medical packaging, IoT solutions, diagnostics, connected and digital health. Together with our clients, we do everything from incremental improvements to radical innovation.
Let's talk HealthTech, MedTech, Product Design, Digital Health
Quality Assurance & Regulatory Affairs
Quality and Regulatory expertise is one of our core strengths. Our QA/RA team is home to subject matter experts and as an ISO 13485 certified partner we help our customers to structure regulatory strategies, development work, processes, and documentation and quality assure the work in accordance with EN ISO 13485 and the requirements of the Medical Device Regulation, MDR 2017/745.
We provide quality and regulatory support to our customers and support them in the process of getting their devices CE marked. Our consultants adopt a pragmatic approach and with their solid experience in the industry they can guide you and navigating the rather complex and confusing landscape of regulatory requirements.
We work with medical devices from Class I to III, both MDR and IVDR, mechanical, electrical, SW, and with SaMD (Software as Medical Device). Our QA/RA team also perform internal audits, training, and can take on the PRRC role for smaller companies.
Let's talk CE marking, safety / performance, risk management, design control, ISO 13485
Startup within Life Science?
We love entrepreneurs and new ideas! Total commitment, energy and passion. Being an entrepreneur is both rewarding and demanding. We know how unpredictable the road can be when developing new products and services. And not least, how difficult – and let’s admit it – how tiresome it can be to have to focus on regulatory requirements from the word go. But we also know how important it is to get off to a good start.
At Yallow, we’re on your side. That’s why we have tailored an attractive offer to give you the best possible start to or continuation of your journey. We give you more bang for your buck. We offer various bespoke sprints with clear and specific content and deliverables.
Let's sprint Design, Prototyping, Engineering, Strategy, Road to CE
Let’s talk! Drop us a line and we’ll take it from there!