Services

Yallow offers a comprehensive suite of services tailored to the unique needs of the medical and health technology sector. From our Design & Product Development division, where we collaborate with clients to transform concepts into cutting-edge solutions, to our Quality Assurance & Regulatory Support services, guiding compliance and market approval, we are committed to delivering excellence at every stage of the product lifecycle. Whether you require assistance with prototyping, regulatory strategy, or market introduction, our dedicated team is here to provide expert support and ensure the success of your healthcare innovation journey.

Our Services

Design & Development Offers

LiDAR

Optical Design

LED Optics

Camera Lab

Microscopy

Optical Metrology + Sensing

Camera Technology

Prototyping

Design & Development

In our Design & Development division, we collaborate closely with clients to conceptualize, prototype, and produce cutting-edge solutions across various healthcare sectors, from advanced medical devices to IoT and digital health platforms. Our multidisciplinary team leverages creativity and technical expertise to deliver impactful products.

Our design and development services are meticulously tailored to meet the unique needs and objectives of our customers, guided by one of the three distinct tracks or stages. In the Research and Development Prototyping phase, we delve into innovative ideas with precision and creativity. Moving forward, our expertise extends to crafting Clinical Prototypes, providing a tangible representation of the envisioned product. To facilitate regulatory submissions, we offer comprehensive Verification and Validation (V&V) services, ensuring adherence to rigorous standards. With a commitment to customer satisfaction, our services are designed to navigate seamlessly through these tracks or stages, bringing your vision to fruition in an iterative manner.

Quality Assurance

Quality Assurance ensures compliance and market approval. With a focus on strategic planning, meticulous regulatory submission support, and diligent adherence to industry standards, our expert team adeptly navigates the complexities of regulatory requirements, ensuring that products consistently meet and exceed the highest standards of quality and safety.

Quality and Regulatory Offers

Medical Device Mapping

Regulatory Strategy

Regulatory Compliance

Quality Management System

Gap Analysis

Harmonized Standards

Audits

UDI Implementation

Risk Management

Quality and Regulatory

Navigating the complex landscape of regulatory compliance, our services offer a comprehensive approach to ensure your products meet the necessary standards. We specialize in the development of effective regulatory strategies, tailored to your unique needs. From expertly compiling submission Dossiers for CE mark, FDA, and other markets to facilitating transparent communication with Notified Bodies, we streamline the regulatory process. With a commitment to excellence, our services provide the support you need for successful regulatory approvals, offering a seamless path to market entry and compliance.

Our Courses

01.

ISO 13485

Gain a deep understanding of quality management systems specific to the medical device industry with our ISO 13485 certification training. Learn how to implement and maintain compliance with ISO 13485 requirements, ensuring the highest standards of quality and safety in medical device manufacturing.

02.

ISO 19011

Master the principles and practices of auditing management systems with our ISO 19011 auditor training. Develop the skills necessary to conduct effective internal and external audits, evaluate compliance with regulatory standards, and drive continuous improvement in your organization.

03.

ISO 14971

Learn the fundamentals of risk management for medical devices with our ISO 14971 training. Understand the principles of risk assessment, mitigation, and control, and gain the expertise to develop robust risk management processes that comply with regulatory requirements.

04.

MDR & IVDR

Learn the fundamentals of risk management for medical devices with our ISO 14971 training. Understand the principles of risk assessment, mitigation, and control, and gain the expertise to develop robust risk management processes that comply with regulatory requirements.

05.

CE Marking

Navigate the CE marking process with confidence with our CE marking training. Gain a comprehensive understanding of the European regulatory requirements for placing medical devices and IVDs on the market, and learn how to prepare documentation, conduct conformity assessments, and affix the CE mark.

06.

UDI

Master the implementation of Unique Device Identification (UDI) requirements with our UDI training. Learn how to create and manage UDI data, label medical devices and IVDs with UDI information, and ensure compliance with UDI regulations in key markets worldwide.

Training & Courses

If you’re seeking to achieve ISO certification, comply with EU regulations, or enhance your risk management practices, our training programs provide comprehensive coverage of key topics essential for success in today’s dynamic regulatory landscape. With a focus on practical application and real-world scenarios, our courses empower participants to implement best practices, mitigate risks, and drive organizational excellence.