CE approval for Thermosaver Rescue Bag

Our collaboration with Thermosaver began with defining the regulatory strategy and pathway to CE approval. In just over six months of dedicated, comprehensive work, we are proud to share that the Thermosaver Rescue Bag has achieved CE approval. Thermosaver AS now holds an MDR-compliant technical file and quality management system, marking a significant milestone in their journey to market.

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.

Innovation assessment with Inven2

Inven2 is the technology transfer office for the University of Oslo and Oslo University Hospital, and one of the largest in Europe. They turn world-class research into innovations, start-ups, and clinical studies that benefit patients and society. We work with Inven2 on their medtech portfolio, providing technical and regulatory assessments and helping sketch strategies that guide promising projects toward market readiness.

Go-to experts for Wilhelmsen Chemicals

Wilhelmsen Chemicals, founded in 1965, is a leading Norwegian producer of high-quality chemical products and well-known brands such as Blåtind®, Cleanline and CERTUS®. With a strong focus on sustainability and safety, they serve both consumer and professional markets. We are proud to support them as a regulatory partner, most recently helping them achieve CE marking for their first medical device product.