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.

 

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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

Examen des rapports au bureau

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

Discussion professionnelle

GxP

  • GMP, Good Manufacturing Practice

  • GLP, Good Laboratory Practice

Environmental normative requirements

  • ISO 14001 Environmental management systems

  • ISO 14021 Environmental labels and declarations

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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

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