Prepare for ISO 13485 Certification

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.

To be registered to the ISO 13485 standard, your company must be audited by an external certification body. Before that takes place, you want to do everything necessary to ensure you are prepared. SimpleQuE believes in a simple, customized approach that begins with a gap analysis, then defines an action plan to prepare you for certification, and more importantly, a maintainable management system. SimpleQuE’s consultants will work with you, using our collective experience and expertise along with tools and processes to prepare you for the certification process.

Our Gap Analysis identifies what needs to be implemented or changed based on the extent to which a company already complies with its current systems. The gap assessment then serves as an action plan, listing each task to be completed. A valuable project management tool, it allows the company to assess its own timing expectations based on the resources available. The gap analysis can also serve as a pre-assessment tool or readiness audit, enabling our ISO 13485 consultants to coach and consult when problems are found.

Our Auditors can conduct a full ISO 13485 audit, evaluating every aspect of your business: every function, every process, every product or service. SimpleQuE’s team of experts has experience from all sides, including ISO auditing for certification bodies to prepare you for your eventual ISO 13485 certification audit.

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Benefits of ISO 13485 Certification

ISO 13485 helps an organization design a QMS that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to provide safe and effective medical devices and products. The benefits of ISO 13485 certification include:

  • Demonstrating compliance with regulatory and legal requirements
  • Ensuring QMS practices that consistently produce safe and effective medical devices
  • Management of risk – reduced risk of non-compliance
  • Increased consumer confidence and satisfaction
  • Improved quality control
  • Increased efficiency and effectiveness and reduced costs


“Certification has further strengthened our industry leadership position by achieving this accomplishment and, Arrowhead Industries looks forward to enhancing our customer relationship and overall performance. The consultant’s experience with the new standards and requirements was the most valuable part of simpleQuE’s consulting services.”

The simpleQuE Advantage

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Whether you have a management system in place or are just developing one, understanding the requirements and having an experienced consultant or auditor by your side is key. Our team members have third-party auditing experience, industry-related work experience, and firsthand knowledge of what is required to pass a certification assessment and maintain certification.

The experts at simpleQuE can keep you on track with their simple, customized approach – “Quality Excellence Made Simple”.

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