Global solutions for medical device manufacturers

A comprehensive portfolio of quality management services

Global solutionsWe understand the extensive product lifecycle for medical device manufacturers, and we have customized a solution package that complements the unique needs of manufacturers and the business needs of each professional involved along the way.


By packaging assessment, certification, standards, specialized training together with our BSI Excellerator tool, we deliver a simple solution driving quality and performance. This comprehensive package also assists customers in driving down costs, improving customer satisfaction, and managing risk more effectively.

We work with thousands of organizations – both large and small and across all industry sectors – on the implementation of standards of excellence so that they can perform better, reduce risk and achieve sustainable growth.


The benefits of a customized solution package

BSI’s solution package streamlines compliance by bringing together certification, specialized training, access to standards, and BSI Excellerator tool to perform audits, raise, monitor and close non-conformities, and track preventative and corrective actions.

The solution also creates transparency to maximize ROI and drive operational performance to the next level. Each component of the package will:

  • Improve quality through world class certification processes
  • Provide timely access to global markets with speed-to-market certification programs
  • Education, knowledge, and improved competency through training
  • Assess the strengths and weaknesses of your industry sector effectively with BSI Excellerator

Using best practice methodology from both large and small organizations, this solution package is designed to eliminate complexity to ensure quick adoption and ease of use.


Quality Management System (QMS) ISO 13485 package

Assessment, auditing and certification services

The BSI solution package for medical device manufacturers covers assessment and certification for ISO 13485. BSI is recognized and accepted around the globe for conducting robust, comprehensive assessments, auditing, and certification. Our leadership role allows clients to have direct access to top industry resources and information.

Specialized training

BSI has developed specific courses for the medical device community that will give your employees the practical knowledge and tools to apply in their everyday business practices. Our accelerated learning processes and dynamic group exercises have made BSI’s training solutions the choice of over 70% of the top medical device manufacturers worldwide.

BSI Excellerator

BSI Excellerator is an in-depth report that analyses the way your management systems are performing. The report is unique to your company and gives you an invaluable resource with which to measure your management systems performance.

Access to Standards

The BSI solution package offers site-wide client access to the key standards of ISO 13485, 14971 and 14969. By providing a full line-up of Standards in our package, we can provide a reference point for your quality management systems to meet requirements for regulations, to manage risk and guidance for ongoing continuous improvement.


Getting your products to market - the BSI certification process

BSI certification process

Please note: Additional steps may be required for products that require consultation outside BSI’s control (e.g. products containing medicines, animal or blood derivatives).