Tag: Quality Assurance

We are happy to announce that Tine Hildisch joins the company as senior advisor. 

Yallow has quickly grown to a trusted partner with subject matter experts in medical and health technology. As a strategic move we are now strengthening the team around the company by appointing Tine Hildisch as senior advisor.  

“Tine bring solid experience that we will benefit from and with her background she will for sure provide necessary guidance to accelerate Yallow in critical areas. We have had a great start on our collaboration with a few strategy sessions already which has been both fun and productive”  CEO, Petter Arlehed.

Tine has a wide experience from the diagnostic industry and public healthcare through her roles in Thermo Fisher Scientific, Roche and Oslo University Hospital. Her knowledge within R&D/innovation, technology, improvement, or transition projects is exiting for Yallow. Further has she deep knowledge in tender management and Norwegian tender law regulation. Tine is certified in Lean, Six Sigma project management and Scrum master. 

“I am looking forward to get to know Yallow, contribute, share my experiences and of course have fun together”
Tine Hildisch 

We are very excited to share the news about our latest addition to the team, PhD Magdalena Karlsson, who joins us as Senior QARA Specialist. 

Magdalena is an experienced senior scientist with extensive experience from the industry and authorities. Her background is comprehensive and include Biomarkers, Statistical Modelling, Bioinformatics, In Vitro Diagnostics, Biotechnology, Clinical Research, and Medical Device Regulation. She joins Yallow as senior QARA Specialist and discipline lead of IVDR. She will also be responsible for our SW compliance team that we are looking to grow and expand in 2023.  

With the new IVD regulations that introduces substantial changes in the regulatory framework for in vitro diagnostic medical devices we expect an increased demand of advising and how to navigate the transition from IVD to IVDR so the timing of bringing onboard an expert like Magdalena could not better. 

“I am very happy to have Magdalena on board. With her we continue our growth and strategy of building a world class team of QARA Specialist. We also add new offerings with her experience in IVD and Software where we see a huge gap of available competence and specialists in the market so I am sure our customers will appreciate Magdalena’s competence in this field” – Petter, CEO Yallow Life Science.

Magdalena joins Yallow after a position as Quality and Regulatory Manager at Oxy Solutions and before that senior advisor at the Norwegian Medicines Agency.  She brings solid and valuable experience that from day one will be appreciated from our customers. 

“I am so much looking forward to become part of this very exciting journey – guiding both existing and new manufacturers to smart and efficient solutions and advancing the healthcare services.” – Magdalena Karlsson.

We are happy to announce that Kean Beng Ho joins Yallow as QA/RA specialist and will strengthen our services within Quality Assurance and Regulatory Affairs. Kean has specialized his career in production process control, quality, and regulatory compliance for more than 10 years. Kean started in oil and gas industry before transitioning into the medical device industry and brings valuable experienced in the field of medical development to the team and our customers. He joins us after a position as Head of QA at Ably Medical and before that GE Healthcare in Horten, Norway. Kean holds a BEng in Chemical Engineering and has vast working experience in dynamic, fast-paced environment and high level of quality and regulatory compliance required sectors.

“I am very happy to have Kean onboard, he is a very positive and nice guy and he joins our already high performing team of experts and will strengthen us with his experience and expertise” – Petter, CEO Yallow Life Science.

“The commitment and dedication of the team of experts to bring products to life and available for use for the better of human lives is over the top and to be able to be part of it, is just amazing” – Kean Beng Ho.

Kean will immediately start working in different client projects within medical and health innovation.  Yallow experience increased demand of expertise within QA/RA and we are immersible proud of working with exciting clients world wide who are developing and innovating medical devices for a better future.