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We are committed to our values of trust, respect and excellence

GROW YOUR
BUSINESS

2013

founded in

800+

Audits Conducted

ISO 13485

Certified

Intro

OUR SERVICES

Expertise that drives
regulatory success

01

Design and Development

MEDICAL DEVICE & DRUG-DEVICE COMBINATION ADVISORY SUPPORT

We provide support to companies developing drug-device combination products.

02

Quality and Regulatory

QUALITY ASSURANCE & REGULATORY AFFAIRS COMPLIANCE

We help you to build or remediate your technical file in compliance with applicable requirements.

03

AUDIT

AUDIT & INSPECTION READINESS

We conduct internal audits of specific processes, or your full Quality Management System.​

04

TRAINING

TRAINING & CAPABILITY BUILDING

Our consultants have experience in offering trainings on behalf of Notified Bodies or at Universities. 

05

LEGAL

AUTHORIZED REPRESENTATIVES

We offer Swiss Authorized Representative Services for Legal Manufacturers outside Switzerland.

06

INNOVATION

AI INTEGRATION & GOVERNANCE

We provide guidance and support to companies developing embedded AI in medical devices.

ABOUT US

A team built for 
regulated industries

We are a team of dynamic consultants with a proven track record for managing projects and providing consulting services to companies within the medical devices and pharmaceutical industries. 

RECOGNITION

Articles & Awards

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March/April 2026

"Advances and Future Directions in Connected
Health"

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International Life Sciences Awards 2022

KAHLITY is the "Best Pharmaceutical & Medical Device Consultancy - Northwest Switzerland"

Contact

CONTACT

Let's start a
conversation

Tell us about your project. Our team will get back to you within one business day.

PHONE

+41 79 927 68 06

ADDRESS

Bruderholzallee 53, 4059 Basel, Switzerland

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