The ISO 13485 Standard was developed to ensure companies meet the regulatory and customer requirements of the stringent medical device field.
Companies looking to service the Medical Device Industry are often required to be certified to ISO 13485. Organizations involved in the design, production, installation and servicing of medical devices may be required to maintain certification by their customers or to reach a new customer base. Changes to this standard follow the ISO 9001 updates from 2015 with a focus on risk, and also include but is not limited to, regulatory requirements and clarification around medical devices files and record keeping. Ledge Inc. can support document upgrades for companies looking at moving from ISO 9001 to ISO 13485, maintaining and improving their current ISO 13485 system and internal audits for the ISO 13485 standard.
Ledge Inc. prides itself on implementing systems that meet the standard with the least amount of business interruption required. Companies producing medical devices must have a robust QMS that provides the company risk mitigation, procedures and tools to ensure products are safe and conform to specifications.
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