«Our company has benefited enormously from Paul Fredriksen’s broad expertise and experience in the implementation of internal audit of the company’s quality system. Paul quickly grasps complex relationships and is very effective when it comes to identify any weaknesses, and provide constructive feedback. We can recommend Paul for businesses that want a well conducted audit.”

Torbjørn Ånestad, Fimreite Software AS.

 

“Paul Fredriksen has held  courses for our firm. The course had emphasized ISO13485: 2012 and ISO9001: 2008 We have now evaluated the course internannly and want to give a positive feedback. We think the course was generally useful, and especially that we got customized course emphasizing 13485 against 9001 was useful for us. We want to come back later this year to get an audit of ISO13485.”

Hans Brudal, QA Manager, Mectro As

 

«We have had the pleasure of using Paul Fredriksen to help design our quality system according to requirements of ISO 13485 and ISO 14971 for quality and risk management in the development of medical devices. Paul is the perfect partner for this: He has a confidence and experience through training that is both interesting and motivating. Through the development and revision of our quality system Paul shows that he has an overview and an insight that is invaluable for adaptation for our needs. Thanks to his extensive experience with FDA regulations, it has also been possible to adapt the system for access to the US market. I can confidently recommend Paul to anyone wanting courses, consultations or audit of its quality system.”

Jonas Tysso, Project and Quality Manager, Cardiaccs AS

 

«I have worked with Paul many times over the years on different projects. I have always found him to be a dedicated and responsible individual. He is persistent when troubleshooting and creative when solving. I highly recommend Paul. He is an asset for any team.»

Gerry Buss, Consultant

 

“Our company (Neusoft Medical Systems Co., Ltd) has benefited enormously from Paul Fredriksen’s broad expertise and experience in the implementation of the company’s quality system. Paul quickly grasps complex relationships and is very effective when it comes to identify any weaknesses, and provide constructive feedback. We can recommend Paul for businesses that want a well conducted audit.

We have had the pleasure of using Paul Fredriksen with his support to pass our external audit. Paul is the perfect partner for this: He has a confidence and rich external audit experience. Through the improvement of our quality system Paul shows that he has an overview and an insight that is invaluable for adaptation for our needs. Thanks to his extensive experience with FDA regulations, it has also been possible to adapt the system for access to the US market. I can confidently recommend Paul to anyone wanting courses, consultations or audit of its quality system.”

Bai Rui, QA manager, Neusoft Medical Systems

 

We have had the pleasure of being introduced to Paul Fredriksen when we started to establish the company’s quality system. Paul has supervised and taught us to understand the requirements for quality and risk management in the development of medical equipment. Thanks to his expertise and experience, we have become much safer in the process. We look forward to further cooperation. We highly recommend Paul.

Leila Yousif, Chief Quality Officer, Ably Medical AS

 

We have had the pleasure of having Paul Fredriksen as a coach through the development of our Quality and Risk management system in accordance with ISO 13485 and ISO 14971 applicable for our medical devices. With the many years of experience in this field, he has provided us with a very good insight into the requirements in combination with the practical approach. His thoroughness in review processes has been very valuable to us, and we are looking forward to further coaching in 2019 which will take us towards our first ISO 13485 Stage 1 audit. We feel grateful to Paul for his genuine interest and willingness to share his knowledge with us. I highly recommend Paul to any medical device company who is in need for a coach in the process of developing a compliant quality and risk management system.

Cecilie Arentz, Quality Manager, GlucoSet AS