ISO 13485 is an International Standard that specifies requirements for a quality management system for organizations providing medical devices and related services.  It is designed to be used throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.  The standard also covers issues like distribution, storage, installation and servicing, and the provision of associated services. In the medical device industry, ISO 13485 is required by regulators in most countries.

Achieving ISO 13485 certification is an important step for manufacturers of medical devices and service providers as it helps an organization design a quality management system that establishes and maintains the effectiveness of its processes.  More importantly, it shows a strong commitment to continual improvement, to provide safe and effective products, and to fulfill customer and regulatory requirements.

This standard integrates well with existing ISO-based quality systems. Whether you have a management system in place or are just developing one, understanding the requirements and having an experienced consultant is key.  Our team members have industry-related work experience and first-hand knowledge of what is required to pass an ISO 13485 certification assessment. SimpleQuE believes in a simple, customized approach that begins with a gap analysis, then defines an action plan to prepare you for certification and a sustainable management system.  Let simpleQuE put you on track for certification.