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ISO Systems
- Does your company want to meet an international standard that outlines the requirements for a comprehensive management system for the design and manufacture of medical devices?
- Does your company want to meet a standard that is recognized by the European Union, Japan, Australia and many other countries?
- Your company requires a suitable registrar to support your certification services for ISO 13485 conformance?
- Does your company need assistance establishing your product or facility conformance to ISO recognized standards?
If the answer to any of the above questions is yes, then you need Axsource Professional services.
- We can help you in meeting ISO 13485:2003 Compliance with the standard is required by Canadian Medical Device Regulation. ISO 13485 is modeled on ISO 9000:2000 with the additional of requirements for documentation and provisions specific to medical devices.
- We can design a single system that meets ISO 13485 requirements unique to your company culture and products. We will prepare you for an audit, to certify that your organization has met the ISO 13485 standard.
- We can perform pre-audit prior to your scheduled surveillance audit?
- We will train your key staff to ensure a smooth and complete implementation.