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!

Condividi questa risorsa

Iscriviti alla nostra newsletter

Le aziende leader si affidano alle nostre soluzioni

Transparency company logo
BrasileFarmaceutica e Scienze della VitaBPM
Pharlab automates training and document management and reduces quality costs by 48% with SoftExpert Suite
Integrated management company logo
TecnologiaSoftExpert SuiteColombia
Sonda Colombia joins SoftExpert to manage business performance and risks
Optimized Certification Compliance company logo
Beni di Consumo
Algodonera Avellaneda, a leading Argentine cotton gin, optimized quality and indicator management with SoftExpert CPM and EQM solutions, enhancing compliance with ISO standards and achieving significant paper reduction
Simplifying Complexity and Costs company logo
Simplifying Complexity and Costs thumbnail image
Trasporto e Logistica
By adopting the SoftExpert platform, Tegma has integrated all its applications into a single repository and collaborative environment, taking advantage of the cloud to simplify management and efficiently scale its business.
Reliable data in real time company logo
PLMBrasileProduzione
Termotécnica strengthens quality management and adopts SoftExpert PLM to optimize the product lifecycle
Operational Efficiency company logo
TecnologiaGRCBPM
Future automates end-to-end processes and achieves gains in efficiency and governance.

Visione Globale con Servizio Locale

La presenza globale di SoftExpert, con operazioni in ogni continente, guida la sua crescita offrendo un servizio solido e personalizzato, su misura per ogni mercato locale.

Contattaci