ISO 13485 Quality Systems
ISO 13485:2016
OMEDtech can help you upgrade to ISO 13485:2016. The transition period for all manufacturers to obtain ISO 13485:2016 certification ends March 2019. We encourage companies to plan ahead to avoid the rush or a lapse in certification. OMEDtech provides a Gap Assessment to begin the transition process. A Gap Assessment for ISO 13485:2016 will assist in identifying missing requirements and will evaluate your current QMS and it’s current compliance with ISO 13485:2016. Our consulting services can help to complete the transition as you update your QMS to ensure you are fully compliant with ISO 13485:2016.
Focused on bringing out your BEST
Quality Systems are a key component to marketing for either US or international compliance. Our broad experience in quality system development, documentation development, implementation, maintenance, and ISO Certification puts you on the fast track to doing business.