ISO 13485 Certification

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What is ISO 13485?

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.

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 certified auditors, many having 3rd party auditing experience, have first-hand knowledge of what is required to pass an ISO 13485 certification assessment and industry-related work experience, which adds value and simplifies the internal auditing process for your business.

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.

Prepare for ISO 13485 Certification


SimpleQuE’s customized approach begins with a gap analysis, then defines an action plan to prepare you for certification and, more importantly, a maintainable management system.

Maintaining Your ISO 13485 Certification


SimpleQuE can help with internal audits, customized training, and consulting resources for your quality management system.

The simpleQuE Advantage Begins Here.
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Let Us Perform Your Gap Analysis and Internal Audit