ISO 13485:2016 specifies requirements for a Quality Management System for medical devices. In compliance with this standard, an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Such organizations can be involved in one or more stages of the life-cycle, including
- design and development
- storage and distribution
- installation or servicing of a medical device, and
- design and development, or provision of associated activities (e.g. technical support).
ISO 13485:2016 is also applicable to suppliers or external parties that provide product, including quality management system-related services to such organizations.
QualityAdvantage provides all the expertise and support needed to implement, maintain and improve an ISO 13485 certified and/or 21 CFR 820 compliant Quality Management System (QMS), including
- QMS Implementation Support, to create and implement an ISO 13485 / 21 CFR 820 QMS ready for guaranteed ISO 13485 QMS certification and/or 21 CFR 820 regulatory compliance, to your schedule
- QMS Transition/Integration Support to transition/integrate your current certified or compliant-only QMS ready for ISO 13485 certification, to your schedule
- ISO 13485 and/or 21 CFR 820 Management Overview, to explain all of the requirements of ISO 13485 and/or 21 CFR 820, as they would apply to your organization and your QMS
- ISO 13485 and/or 21 CFR 820 Compliance Review, to provide a clear understanding of “where you are, compared with where you need to be” to achieve ISO 13485 QMS certification and/or 21 CFR 820 compliance. So much more than just a “gap assessment!”
- QMS Internal Audit with Qualified/Certified Auditor of your existing ISO 13485 QMS and/or 21 CFR 820 Quality Management System, with a comprehensive report of results with recommendations
- QMS Internal Auditor Training to train and certify a group of your personnel to audit your ISO 13485 QMS and/or 21 CFR 820 QMS now, and for years to come
- QMS Internal Auditor Training with Audit Mentoring, to train and certify a group of your personnel, and then to mentor them as they audit your entire ISO 13485 QMS and/or 21 CFR 820, qualifying your Auditors to audit your QMS now, and for years to come