Hello Mikkel!

2023 has started with a bang with exciting new clients and projects for Yallow. The timing of welcoming a new team member could not be any better and we are thrilled to welcome Mikkel Lager to Yallow who joins us as Embedded Software engineer and will strengthen our Design & Development team within electronics and medical device software. 

“It’s a strategic milestone to also include medical software as a core competence in our design team. We are experiencing increased demand within medical software, and we are excited about the future within this field” – Petter Arlehed, CEO – Yallow Life Science

Mikkel holds a MSc within Biomedical Electronic Engineering from the University of Southampton and joins us after his recent position as product development engineer at MedStorm Innovation AS. Mikkel has valuable experience from both hands-on SW development and IEC 62304 Medical Device software and fit perfectly in the team of medical device specialists at Yallow.

“There are many reasons why Yallow but having the opportunity to work with a highly competent team on a wide range of exciting medical projects is one of the main reasons why I found this opportunity so attractive. I will now work with a diverse set of team members, projects and clients with a clear WHY and purpose.”
– Mikkel Lager 

Mikkel is a passionate embedded developer and has worked with many different aspects of medical development, from embedded software, regulatory documentation, and manufacturing which gives him a great understanding of how to efficiently go from idea, to prototyping and all the way to mass production. 

“I am excited to get Mikkel onboard in the development team! His background within medical devices and his experience with embedded engineering is a great addition and allow us to take on even larger and more complex projects.”– Eirik Dyrset, CTO

Welcome Tine!

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 

Welcome Magdalena!

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.

Say Hello to Kean!

Kean Ho Beng together with a colleauge!

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.  

CE approval for Thermosaver Rescue Bag

Medicis using 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.

“The journey has been intense, challenging, and fun. It’s great working with committed people and the collaboration with Thermosaver and other partners in this project has been great” – Ira Sharma Sankhayan, CCO Yallow Life Science. 

The product is a medical device Class I product and for Thermosaver the CE mark is a recognition of safety, quality, and compliance.

“The process has been challenging and demanding and we would never pull this off without the superb support from Yallow. Now we are ready for market introduction as a medical device.” –  Ketil Thorsen, CEO Thermosaver 

Welfare with smart sensors and advanced algorithms

Varda Care company photo

Welfare technology company Varda Care is using smart and invisible sensors in combination with advanced algorithms to improve quality of life at nursing homes. By monitoring health data and utilizing data analytics the solution can detect early signs or symptoms of health deterioration and improve the health personnel’s decision-making. A user-friendly technology that could be integrated into the patient’s favourite chair or bed to map their health status around the clock without disturbing them.

“This is in the sweet spot of our competence of digital health and connected care!”

– This is in the sweet spot of our competence of digital health and connected care and we are very proud of having Varda Care as a client. We are looking forward to working with Varda Care and helping them achieve their goals. It is inspiring to work with the Varda Care team and be a partner in the development of a meaningful service. We are excited to continue the collaboration in 2022, says Ira, Chief Compliance Officer, Yallow.

“That’s why we contacted Yallow to assist and guide us through this process”

– The regulations and requirements are experienced as rather complex and sometimes overwhelming. That’s why we contacted Yallow to assist and guide us through this process. They have proven to be a trusted partner with deep knowledge and experience in this domain. The team at Yallow ensure progress and in a positive meaning force us to keep the pace up towards certification, says Varda Care Chief Marketing Officer Diana Meldal.

The Ålesund based team in Varda Care is now focused on certification and looking forward to introducing their new technology on the market in 2022.

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. 

“An important milestone in our company’s history.”

– This is an important milestone in our company’s history. It has always been our plan to get this certification but to manage this within our first year as a company is beyond our expectations. Very grateful, extremely impressed and proud of what the team has accomplished, says Petter Arlehed, CEO at Yallow Life Science.

This certification confirms our competence in delivering core quality and regulatory services for medical devices according to internationally recognized standards. It positions the company as a trusted design and development partner.

“This means we are a trustworthy and reliable partner.”

– This means we are a trustworthy and reliable partner that can deliver compliant services. Of course, it is a benefit for our customers. Yet another proof of our high quality services within medical device development, says Ira Sharma Sankhayan, CCO at Yallow Life Science.

Say Hello to Amrita!

Amrita with co-workers

Amrita Kaur joins Yallow as QA Engineer.

Born in Norway, raised in India, and Master’s degree from England, Amrita has a diverse background and a global mindset so no surprise it was a good match with Yallow!

“Thrilled to be a part of such an exuberant bunch that not only are passionate about providing the best services to their clients but also have such incredible brand ideals”

– Amrita Kaur 

Amrita holds MSc in Molecular Biotechnology from the University of Birmingham, UK, and brings valuable work experience from the start-up BioCHOS where she worked with R&D of novel plant protection products as well as project management and patent documentation. She joins Yallow after her latest position at Tine AS where she worked with projects management, Quality Assurance, and implementation of QMS systems according to relevant ISO standards.

“I am very pleased to announce that our team is growing. Amrita Kaur has joined as our new QA Engineer- working with Quality and Regulatory.  Her background in implementation of ISO standards and a strong academic background is a great leverage to the team. We know you’re going to be a valuable asset to our company and can’t wait to see what we accomplish together. Please join us in welcoming our new team member”

– Ira, Chief Compliance Officer, Yallow

Improving quality of life with Hepro AS

Kid rides mobility aids bike

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.

“We have been working with Hepro on a few projects already and the collaboration has been great. We are of course very proud to continue as a trusted partner within design and development for Hepro”

– Petter Arlehed, CEO Yallow Life Science 

Yallow assist Hepro with mechanical engineering and industrial design in different projects but with the same end goal – Empowerment and increased quality of life. 

“It’s very exciting to work closely with the development team at Krabat developing new products for children” -Thomas Kjesbu Hansen, senior product developer and industrial designer at Yallow. 

“Yallow have shown us solid competence and that they work creatively and quickly. Very easy to cooperate with.”

– Geir Tore Jakobsen, CEO – Hepro As

Next generation hypothermic rescue bag

Nowegian company ThermoSaver has developed a new concept based on a repeatedly expressed a need for a new and more effective hypothermic rescue bag. The bag has been developed by researchers from SINTEF, medical experts from Haukeland University Hospital and three industry partners, supported by the Norwegian Research Council and Innovation Norway.

“We are very happy working with ThermoSaver and we share their passion and entrepreneurial spirit developing a meaningful product that ultimately can save lives”

– Petter, CEO Yallow Life Science.

The rescue bag is developed as based on scientific methods and laboratory testing and provide a user friendly and efficient product used in life threatening situations.

Thermosaver’s vision is to save lives by offering an all-in-one prehospital hypothermic rescue bag that follows the pasient from an incident to the hospital, with reusable components at an affordable price.

The ThermoSaver is a medical device Class I product and Yallow Life Science is proud to be chosen as a partner in commercializing and getting the rescue bag CE marked.

“Getting the ThermoSaver CE marked as medical device give us important market access and will differentiate the rescue bag compared to most competitors. The MDR process is challenging for a start up with limited resources so the support from Yallow is important in order get us through this process”

– Ketil Thorsen, CEO ThermoSaver.