ISO 13485 is the most widely known quality standard in medical device industries. It is very similar to ISO 9001, but brings a specific approach to subjects like documentation, traceability, inspection, sterilization and others. Medical devices companies follow ISO 13485 to ensure they meet the customer requirements, and also the applicable regulatory for the marketplaces where the medical devices are supplied.
The emerging of new diseases and the phenomenon of population ageing is increasing fast the demand for medical devices. In an environment where margins are slim and government regulation is high, medical devices suppliers need to overcome the challenge of innovate and provide high quality equipment’s 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 the 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 the QMS efficiency, reducing rework and waste. With online collaboration capabilities, the organization and managers can communicate and be updated about the quality initiatives, involving more users, teams, offices and business units with a systematic and unified approach that ensure the maintaining and effectiveness of the QMS.
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- 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 meets 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.