working for the world’s leading Pharma & Medical device companies.
We have a highly qualified and experienced team with background`s working for the world`s leading pharmaceutical, medical device companies and regulatory bodies. Our team has a wealth of experience in medical devices/combination products and interactions with health authorities on Human Factors related issues.
We are Human Factors experts with a solid track record in developing and implementing strategies to successfully meet regulatory expectations. We are experienced in running Human Factors studies globally across a wide range of product types and therapeutic areas.
We are a ISO13485:2012 certified service provider with a scope for provision of professional services in Human Factors Engineering to manufacturers of medical devices and combination products. Our staff are all certified in current Good Clincial Practice and our quality system includes specialized processes to ensure data integrity and compliance to relevant human subject research protection laws/ regulations.
MSc Healthcare Human Factors
BSc Product Design
Head of Human Factors - Roche
Principal HF Scientist - Novartis
Snr. Designer - Cambridge Consultants
Head of Quality Management & Regulatory Affairs
MSc Electrical Engineering
Founder & CEO - confinis
Lead Auditor - SQS (Notified Body)
Head of Project & Risk Mgmt - Ypsomed
Dipl. Ing. FH, Biotechnology
Master of Advanced Studies MAS,
Applied Psychology - Human Factors
Medical Device Inspector – Swissmedic
Project Leader – Roche Diabetes Care
Research Scientist - Disetronic Medical Systems AG
Bioinformatics Software Engineer – Genentech
Device/ Software Engineer – University of California San Francisco