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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint745,110 companies indexed · Last updated: today
DirectoryBusiness & Technical ServicesManagement ConsultingLausanneKobridge Sàrl
Kobridge Sàrl Logo
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Kobridge Sàrl

Summary

About the company

The core activity of Kobridge is to advise and support medical device manufacturers in regulatory affairs and quality management, particularly in the approval and certification of medical devices for the global market, including Europe, the USA and Canada.

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Products & services

Industry:Management Consulting
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Medical Device Consulting
Regulatory affairs and quality assurance for medical devices, including global market submissions and support for manufacturers.
Europe Medical Device Registration
Compliance with CE marking requirements and MDR 2017/745 for medical device registration in Europe.
Canada Medical Device Registration
Approval and registration support for medical devices in Canada, including Health Canada regulatory requirements.
FDA Clearance
Support for obtaining FDA clearance by meeting the required regulatory requirements for medical devices.
ISO 13485 Beratung
ISO 13485 requirements for medical devices, addressing quality management systems and regulatory purposes.
Risk Management ISO 14971
Risk management according to ISO 14971, including training, gap analysis and implementation.
Clinical Evaluation
Clinical evaluation compliance under MEDDEV 2.7.1 and MDR, including literature search, appraisal and clinical evaluation reports.
Biological Evaluation
Biological safety evaluation under ISO 10993, including toxicological assessment, biocompatibility and biological evaluation reports.
MDSAP Beratung
Preparation for MDSAP compliance, quality system upgrade, system maintenance and mock audits.
WHO prequalification of diagnostics
Preparation for WHO prequalification of diagnostics, including gap assessment, mock audit and full process assistance.
Internal Audit
Internal and supplier audits as part of medical device consulting services.
Software Development Life Cycle
IEC 62304 compliance support for medical device software, described as an approach and service for development lifecycle compliance.

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Location

Rue Caroline 2
1003 Lausanne
Opening hours
Mon
09:00 - 18:00
Tue
09:00 - 18:00
Wed
09:00 - 18:00
Thu
09:00 - 18:00
Fri
09:00 - 18:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Limited Liability Company
UID
CHE-368.186.221
Founded
2021 · 5 years
Last commercial register change
July 20, 2022
Employees
11 to 20

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