ISO 13485

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The Challenge

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.

ISO 13485 Solution

SoftExpert offers the most advanced and comprehensive software solution for compliance management that meets the demanding needs of various global regulations.  SoftExpert Excellence 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.

Business Process Modelling

Business Process Modelling

Audit Control

Audit Control

Risk Assessment

Risk Assessment

Product Management

Product Management

Main 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.

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