ISO 13485 Certification

Established by International Organization for Standardization (ISO), ISO 13485 is a global regulatory standard for companies that design and manufacture medical products, devices and software. 

Compliance with this standard is established from auditing and certification. ISO 13485 certification is required by the manufacturers to sell their medical products in the international market. Similar to ISO 13485, 21 CFR Part 820 compliance is required for medical products sold in US market.

LMG provides assistance in ISO 13485 implementation which consists of

·        Preparing Quality Manual Documentation

·        Preparing evidence records to establish the conformity of regulation.

·        Creating awareness about the ISO standards among team members.

·        Arranging Internal Auditing to check the QMS is effectively implemented             and maintained.

·        Arranging for Certification body audit.

·        Maintain ISO 13485 implementation thereafter.

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