ISO 13485

ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

Safety and quality are must have features, both are non-negotiables in the medical devices industry. Regulatory requirements are stringent throughout any medical device’s product’s life cycle, including service and delivery. Thus, ISO 13485 is a prerequisite for access to most major markets worldwide. Having this certificate enhances the ease of business and provide access to a wider market.

MAKE SUCCESS AND GROWTH A PRIORITY

For more information on how Lean QA can help you get/retain this certificate please contact

We can help you with ISO 13485 in the following ways

Gap Analysis
Develop / improve processes for shall requirements
Training on QMS Standard & Core Process requirements
Coordinate & conduct Internal Audit program
Coordinate & conduct Management Review
External audit coordination and support
Audit Findings / Corrective Action Assistance
Lead Continual Improvement Project
Consult on Quality Related Issues
Consult on Customer Quality clauses, terms, and conditions
Industry & QMS Insight → Monthly Email/Call
Hosting Documentation on Lean QA Portal
Audit Tested Templates

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