ISO 13485 Medical Devices
ISO 13485 is the medical device industry's quality management system (QMS) standard. The scheme specifies the requirements for a quality management system for medical devices.
Quality Management System Certification
Be successful in the Medical sector and meet ever-changing market demands requires clearly defined processes and continuous improvement at every stage - from development to sales. ISO quality management systems, accepted internationally and by the medical field, bring together all important information within the company and improve business operations.
ISO 13485 certification
ISO 13485 is a universal standard that extends its benefits to organizations involved in every facet of the medical device product life cycle. Regardless of your organization's type, size, or the specific medical products you offer, ISO 13485 can be integrated into your operations. Its adaptability allows it to be employed from the initial conceptualization of a medical device through to production, post-production, and the final decommissioning and disposal stages.
Benefits of management system certification
Management systems certified according to international standards, by accredited bodies like Kiwa, bring transparency, efficiency, satisfied employees, improved risk assessment and control, profitability, and happier customers. Management systems enable you to systematically improve quality management, environmental and social responsibility efforts, health, safety and medical-specific topics. Discover what Kiwa can do for you in this sector.
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