Back to top
SoftExpert no LinkedIn SoftExpert no Twitter SoftExpert no Facebook SoftExpert no Youtube
ISO 13485

Overview

ISO 13485 is the most widely known quality standard in the medical device industry. It is very similar to ISO 9001, but brings a specific approach to subjects like documentation, traceability, inspection, sterilization and others. Medical device companies follow ISO 13485 to ensure they meet customer requirements, and also the applicable regulations for the marketplaces where the medical devices are supplied.

The emergence of new diseases and the phenomenon of population aging are quickly increasing the demand for medical devices. In an environment where margins are slim and government regulation is high, medical device suppliers need to overcome the challenge of innovation and provide high quality equipment at lower costs.

SoftExpert offers the most advanced and comprehensive software solution for compliance management that meets the demanding needs of various global regulations. SoftExpert Excellence Suite (SE Suite) helps companies to comply with ISO 13485, while lowering costs, maximizing success, increasing productivity and reducing risks.

The SoftExpert solution enables organizations to easily meet ISO 13485 requirements, providing resources to manage documents, processes, risks, audits, non-conformances, customer complaints, KPIs, product data and others, boosting QMS efficiency and reducing rework and waste. With online collaboration capabilities, the organization and managers can communicate and be updated about quality initiatives, involving more users, teams, offices and business units with a systematic and unified approach that ensures the maintaining and effectiveness of the QMS.

Download Center

Select the materials of interest and fill out the form to download:
More Resources:
Please wait...

  • OpetrecOnline access to wherever we offer services ensures us speedy responses, through reliable and updated information, which, in turn, facilitates decision making and customer satisfaction.

    José Andrade – Opetrec Manager

  • MenegottiOur productivity and reliability increased greatly. The software helped us to meet the ISO/TS 16949 standard requirements, providing security in the daily routine of the Engineering area and auditing, while easily proving full compliance with the standard and customer requirements.

    Jeferson R. F. dos Santos – MENFUND Unit Manager

  • CTA-ContinentalSE Document has provided the means to streamline our document control, through excellent drilldown options for searching and registering documents, a systematic workflow
    tool for sending pending tasks to system users, as well as really cutting down on the need for printed copies.


    Ângela Fischer

  • Coca-ColaThe implementation of SE Action streamlined our continuous improvement process for managing actions, especially through the workflow functionality. This facilitates the verification of occurrence causes and drafting correction actions.

    Gustavo Martins – Quality Department Assistant

  • Group RoullierSE Document completely meets our document control requirements, facilitates retrieval, and manages the entire document revision process.

    Janaina Salatti – Quality Supervisor

  • CoinduThe SoftExpert facilitates and speeds up activities, and the system was considered highly suitable for the renewal of ISO/TS 16949 and ISO 14001.

    Cristina Pereira – Gerente adjunta de Informática

  • Universal Leaf TabacosSE Document manages ISO standardization documentation to facilitate compliance, as well as all other document types. The workflow system provides great distribution copy control, approval, revision, printed copies, and document retrieval search capabilities. Currently, there are over 1,100 users and 3,500 registered documents.

    Carla Regina Schmitt

  • Mitsubishi MotorsWe have achieved improved dependability as well as standardization in our processes to assure measurement consistency and the required monitoring to verify conformity in our products. This adds enhanced safety and quality to our customers.

    Helton Calaça – SPC Technical Support

  • CarrierSoftExpert Solution has streamlined data sharing for our quality system and has contributed to reducing impacts on the environment through doing away with the need for storing piles of original and obsolete paper documents for auditing purposes.

    Solange Amaral – Human Resource Analyst

  • Laboratório GloboThe SE Project was implemented quickly and the time required for the adoption of the solution by the users was quite natural, considering that the pharmaceutical segment is legally required to work with reliable and secure records that guarantee the quality of products and do not represent risks to the population.

    Randel Moreira – IT Manager

Screenshots (Click to Enlarge)

Business Process Modelling
Risk Assessment
Audit Control
Product Management

Benefits

  • Standardize and streamline regulatory and legal compliance management.
  • Reduce efforts to effectively comply with ISO 13485 and other regulations.
  • Drive the efforts to develop the workforce and improve business process across the enterprise.
  • Ensure the delivery of medical devices that consistently meet customer requirements.
  • Proactively identify and manage potential risks, saving your budget.
  • Centralize and get complete visibility of product development processes and product portfolio.
  • Simplify the development, review, and approval of new medical devices and related documents.
  • Accelerate the investigation of quality deviations and customer claims.
  • Run process and departmental audits and reduce organizational vulnerability.
  • Strengthen business relationships with stakeholders, suppliers and patients. .

About SoftExpert

SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs.

Founded in 1995, SoftExpert has a rich history of innovation and growth as a true industry leader. More than 300,000 users from 2,000 organizations worldwide trust SoftExpert applications to ensure the highest standards of efficiency, quality and innovation for their products, services and processes.

By streamlining and integrating all levels and operations, SoftExpert applications also enable organizations to address an ever-increasing variety and number of international standards, laws and regulations that affect business operations by delivering enhanced compliance capabilities based on industry-specific best practices.

SoftExpert solutions are used by leading corporations in all kinds of industries, including consumer products, automotive, food and beverage, mining and metals, high tech and IT, energy and utilities, government and public sector, financial services, transportation and logistics, healthcare, education, medical devices and many others.

Along with its extensive network of resellers spread across all continents, SoftExpert also provides hosting, implementation, post-sales support, and validation services for its solutions to ensure that customers realize the maximum value from their investments.

Share
Follow Us
Contacts

Comercial - sales@softexpert.com   Partners


Ombudsman - ombudsman@softexpert.com

Copyright © SoftExpert Software for Performance Excellence.
All trademarks, trade names, service marks, and logos referenced herein belong to their respective companies.