YALLOW LIFE SCIENCE

We provide consultancy services in design and development and quality assurance and regulatory affairs, primarily in the medical device industry.

ISO 13485 CERTIFIED

Design & Development

Regulatory Affairs

Quality Assurance

Training & Courses

At Yallow, we offer a comprehensive range of services aimed at driving innovation and transforming healthcare. Our expertise spans across the entire product lifecycle, from concept to commercialization, ensuring that our clients receive end-to-end solutions that meet their unique needs and exceed industry standards.

Innovating Better Life

Yallow takes great pride in being a part of Vinngroup, a distinguished consortium of specialist companies. Through our collective expertise, we offer a diverse array of skills and services, enabling us to collaborate effectively with our clients and drive their success. Our affiliation with Vinngroup allows us to leverage the strengths of each member company, providing comprehensive solutions tailored to meet the unique needs of every client. If you are interested in learning more about the other companies that make up Vinngroup and the range of services they offer, you can find additional information here

References

CE approval for Thermosaver Rescue Bag

The collaboration with Thermosaver started at the end of Q2-21 by establishing the regulatory strategy and pathway to CE approval. Now after a little over 6 months of dedicated and comprehensive work by the team we are very pleased to announce that the Thermosaver rescue bag is CE approved and Thermosaver AS has an MDR compliant technical file and QMS.

Improving quality of life with Hepro AS

Yallow Life Science are pleased to announce continued collaboration with Norwegian welfare company Hepro AS and their technology department and also the department for children aids; Krabat. Hepro AS have more than 30 years of experience designing products to help people live more independently. Their goal is to improve your coping skills, safety and quality of life ​by providing mobility aids.

Support continuous improvement at Epiguard

Yallow is supporting Epiguard in its mission as the industry leader in the patient isolation unit market with their sophisticated technology. "Yallow's partnership has been invaluable to us. Recently, an internal audit conducted by Yallow enabled us to enhance our processes and successfully pass a Certification Body audit with zero nonconformities," said Toan Tran, Vice President QA&RA at Epiguard.

Yallow Life Science receives ISO 13485 certification

We are proud to announce that we have received SS-EN ISO 13485:2016 certification for Consultancy services focused on Quality Assurance, Regulatory Compliance and Design & Development for MD (medical device). ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.