Consulting for medical device approvals and quality systems in international markets.

Kobridge Consulting Ltd.

Seoul (KR) · Lausanne (CH)New on Amplifa

2007Founded

2-10Employees

Seoul, LausanneLocations

About Kobridge Consulting

Kobridge Consulting is a consulting agency for medical devices with a focus on Regulatory Affairs and quality systems. Founded in 2007, the company supports medical device manufacturers with international market approvals, particularly for Europe, the USA, Canada and South Korea. The service portfolio includes CE marking, FDA and 510(k) procedures, Health Canada registrations, MFDS approvals in Korea, MDSAP and WHO prequalification of diagnostics. In addition, Kobridge supports the implementation of ISO 13485 and GMP quality systems, conducts internal audits and prepares technical documentation including biological evaluation, software validation in accordance with IEC 62304, sterilization and risk management in accordance with ISO 14971. The company also offers training, for example on the Software Development Life Cycle, and acts as local representative or license holder in South Korea. Kobridge operates from locations in Seoul (South Korea) and Lausanne (Switzerland) and works in English, French and German.

Site: Lausanne
Processes: Regulatory Affairs consulting for medical devices, CE marking (Europe), FDA/510(k) approval (USA), Medical Device Registration Canada (Health Canada), MFDS approval (Korea), MDSAP, WHO Prequalification of diagnostics, ISO 13485 quality management systems
Materials: Regulatory Affairs, Quality Systems, Audits and Training, Technical Documentation
Certificates: ISO 13485 (consulting/implementation), ISO 14971 risk management, IEC 62304 software validation
Founded: 2007
Employees: 2-10
Industries: Medical Technology, Biotechnology, Diagnostics

01
Requirements and market analysis
02
Regulatory strategy
03
Technical documentation
04
Approval submission (CE, FDA, MFDS, Health Canada)
05
Audit and QM support
06
Training and support as local representative

Services and Areas of Expertise

Regulatory Affairs

Consulting on international approval procedures such as CE marking, FDA/510(k), MFDS and Health Canada.

Quality Systems

Establishment and maintenance of ISO 13485 and GMP quality systems for medical device manufacturers.

AUD

Audits and Training

Internal audits as well as training on ISO 14971 and the Software Development Life Cycle.

DOC

Technical Documentation

Biological evaluation, software validation in accordance with IEC 62304, sterilization and risk management in accordance with ISO 14971.

Locations

Seoul

Headquarters / Office

Materials: Regulatory Affairs, approvals, local representation

Kyobo Securities Building, 97 Uisadang-daero, Yeongdeungpo-gu, 07327 Seoul

Lausanne

Office

Materials: Regulatory Affairs, quality systems

Rue Caroline 2, 1003 Lausanne

Industries

Medical TechnologyBiotechnologyDiagnostics

Additional services

Regulatory Affairs consulting for medical devicesCE marking (Europe)FDA/510(k) approval (USA)Medical Device Registration Canada (Health Canada)MFDS approval (Korea)MDSAPWHO Prequalification of diagnosticsISO 13485 quality management systemsGMP quality systemsInternal auditsTechnical documentationBiological evaluation / biocompatibilitySoftware validation (IEC 62304)SterilizationRisk management (ISO 14971)Training (Software Development Life Cycle, Risk Management ISO 14971)Local representative / license holder in South Korea

Quality and Compliance

Kobridge supports clients in complying with standards such as ISO 13485, ISO 14971 and IEC 62304 as well as with MDSAP and WHO prequalification.

Evidence	Seoul
ISO 13485 (consulting/implementation)
ISO 14971 risk management
IEC 62304 software validation

Company History

2007
Foundation of Kobridge Consulting; support of medical device manufacturers in Regulatory Affairs and quality systems.