ABOUT US

We specialize in evaluating the use related safety, effectiveness and usability of medical products.

BACKGROUND

working for the world’s leading Pharma & Medical device companies.

BACKGROUND

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.

EXPERT UNDERSTANDING

of regulatory requirements & expectations.

EXPERT UNDERSTANDING

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.

SPECIALIZED QUALITY SYSTEM

to medical device/ combination product Human Factors.

SPECIALIZED QUALITY SYSTEM

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.

WE ARE

A provider of Expert Medical Human Factors Services.

Lee Wood

LEE WOOD

Co-founder, CEO

MSc Healthcare Human Factors
BSc Product Design

BACKGROUND:

Head of Human Factors - Roche
Principal HF Scientist - Novartis
Snr. Designer - Cambridge Consultants

Beat Steffen

BEAT STEFFEN

Co­-founder, Chairman,
Head of Quality Management & Regulatory Affairs

MSc Electrical Engineering
Executive MBA

BACKGROUND:

Founder & CEO ­- confinis
Lead Auditor - SQS (Notified Body)
Head of Project & Risk Mgmt - Ypsomed

Andrea Schüetz Frikart

ANDREA SCHUETZ FRIKART

Senior Consultant

Dipl. Ing. FH, Biotechnology
Master of Advanced Studies MAS,
Applied Psychology - Human Factors

BACKGROUND:

Medical Device Inspector – Swissmedic
Project Leader – Roche Diabetes Care
Research Scientist - Disetronic Medical Systems AG

Isabel Menz

ISABEL MENZ

Managing Director Germany

MSc Human Factors
BSc Psychology

BACKGROUND:

UX/Healthcare Consultant - GfK
Human Factors Engineer - Cambridge Consultants

Matt Chen

MATT CHEN

Consultant

BS Bioengineering

BACKGROUND:

Bioinformatics Software Engineer – Genentech
Device/ Software Engineer – University of California San Francisco

Viky Verna

VIKY VERNA

Senior Consultant

MSc Biomedical Engineering
MSc Pharmacy

BACKGROUND:

Combination Product Branch Lead,
Compliance Officer high risk
medical devices – US FDA

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MARTINA BECKER

Consultant

MSc Human Factors
BSc Transportation Systems

BACKGROUND:

Human Factors/Project Engineer – Bertrandt
Human Factors Expert – Airbus Group Innovations

florian

FLORIAN GOTHUEY

Consultant

MSc Bioengineering
BSc Life Science and Technologies

BACKGROUND:

Human Factors Engineering Expert – Novartis
Human Factors Engineering Manager – Debiotech SA

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INKEN LOHMANN

Intern

cand. MSc Human Factors
BSc Business Psychology

BACKGROUND:

Working Student UX– GfK