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Kahlity 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

OUR SERVICES

Intro

Expertise that drives
regulatory success

As a consultancy provider to the medical device, diagnostics and pharmaceutical industries, our team of consultants provide you the following services:

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.

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