Ebook

ISO 13485:2016 – What You Need to Know

Read this eBook and be better prepared to conduct a smooth transition of ISO 13485 at your organization.
ISO_13485_2016_What_You_Need_to_Know_8ccff894c1_page-0001.jpg
ISO_13485_2016_What_You_Need_to_Know_8ccff894c1_page-0002.jpg
ISO_13485_2016_What_You_Need_to_Know_8ccff894c1_page-0003.jpg
The International Organization for Standardization (ISO) released a major review of its ISO 13485 standard. This review includes several important changes for both medical device industries that already have this certification and those looking to develop and implement a quality management system (QMS).
With the changes, many questions come up:
  • How long will ISO 13485:2003 continue to be recognized and audited to?
  • What is the timeline for ISO 13485:2016 implementation?
  • How will organizations with ISO 13485:2003 certification be affected by the new standard's changes?
  • What benefits can the organization expect with the new standard?
In this eBook, you will find the answers to these and many other questions and will be better prepared to conduct a smooth transition at your organization. Download it now!
Share this resource

Subscribe to our newsletter

Trusted by leading companies

Credit approvals are now 80% faster company logo
Financial Services
Primacredi CrediSIS slashes credit approval time by 80% with SoftExpert
Optimized Calibration Management company logo
Automotive
Riosulense increases efficiency by calibrating over 9,000 equipments
Automated and integrated service across departments company logo
BrazilECMESM
Marquise Group integrates processes and results within a unified digital ecosystem powered by SoftExpert
Centralized management of activities company logo
Centralized management of activities thumbnail image
Transportation & LogisticsISO 9000ISO 45001
See how Portonave enhanced its audit processes with SoftExpert's solution.
Safe decisions company logo
Automotive
Isuzu Motors unit in Turkey acquires SoftExpert solution to boost operational efficiency.
Process automation company logo
Public Sector & AssociationsSoftExpert Suite
Reciprev's pension request is now 100% digital with SoftExpert

Global Thinking with Local Service

SoftExpert's global presence, with operations on every continent, drives its growth by delivering strong, personalized service tailored to each local market.

Contact us