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

ABOUT US

Who we are?

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. We are experienced in managing people in a multicultural and interdisciplinary environment. To provide the best value for our customers and exceed their expectations, we rely on our large network and partnerships. We are committed to our values of trust, respect and excellence.

KAHLITY holds a Personnel Staff Leasing Licence issued by the Canton of Basel-Stadt.

Social impact

Our dream is to contribute to provide a better life for people by supporting the healthcare industry. We believe in achieving our dream by working with passion, and going forward within a spirit of service. We are devoted to invest our time and energy for companies caring about finding a right balance between an economic growth, and social and environmental concerns.

OUR NORMATIVE AND REGULATORY EXPERTISE

Medical device regulatory requirements

EU-MDR, Medical Device Regulation (EU) 2017/745
EU-IVDR, In-Vitro Diagnostics Regulation (EU) 2017/746
MedDO, Medical Device Ordinance
IvDO, In-vitro Diagnostics Ordinance
21 CFR Part 820 Quality System Regulation
21 CFR Part 4 Regulation of Combination Products

Medical device normative requirements

ISO 13485 Medical Devices
MDSAP, Medical Device Single Audit Program
ISO 14971 Application of risk management to medical devices

Management Systems

ISO 9001 Quality Management
ISO 15189 Medical Laboratories
ISO 19011 Guidelines for auditing management systems

GxP

GMP, Good Manufacturing Practice
GLP, Good Laboratory Practice

Environmental normative requirements

ISO 14001 Environmental management systems
ISO 14021 Environmental labels and declarations

Sterilization normative requirements

ISO 11135 Ethylene Oxide Sterilization
ISO 10993-7 EO residuals
ISO 11137 Irradiation sterilization
ISO 17665-1 Moist heat sterilization
ISO 17664 Information to be provided by the manufacturer
ISO 11737-1 Bioburden
ISO 11737-2 Sterility

OUR MAIN MEDICAL DEVICE EXPERTISE

Dental implants
Orthopedic implants
Hearing Aids
Software
Apps
In vitro diagnostics
Combination Product
Single-use devices
Surgical and laboratory instruments