© 2019 by LIMI Consulting Service

Services

It is our goal to help you enter Kazakhstan medical device market with an effective and safe products

For detailed information please write to us info@lcs-kz.com

Our team has 10+ years of national and international medical device regulation experience, particularly in the quality control laboratories. We provide you detailed document expertise, registration dossier file preparation according to national and Eurasian Economic Union rules and qualified registration support at any stage including registration certificate issue.

Registration services

LCS via cooperation with accredited laboratories offers you laboratory quality control services, including:

- Physico-chemical testing

- Performance testing

- Technical testing

- EO residual testing

- Stability and shelf-life testing

- Biocompitability testing

- Sterility testing

Laboratory services

LCS team offers you detailed consulting services according to the national orders regarding medical devices and medicine regulation in Republic of Kazakhstan and common rules of Eurasian Economic Union. Furthermore, we can provide information about recognition of registration approvals between 5 countries (Russian Federation, Kazakhstan, Belarus, Armenia, Kyrgystan) in the EEU.

Regulatory consulting

Our company members hold an ISO 17025 internal auditor certificates and ISO 13485 QMS training certificates, and are competent in conducting on-site and documentary QMS audits. We offer:

- On-site QMS (pre) audits of manufacturers and laboratories

- QMS documentation

- Internal standards/Product specification

- Scope of accreditation 

QMS Compliance

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