ISO 13485 is an international Medical Devices standard developed by International organization for Standardization to utilize the benefits of quality management systems toward the design, development, production, installation and servicing of medical devices and related services. Medical Devices are products designed to diagnose, treat, investigate and augment human functions and diseases

ISO 13485 Highlights

• Effective implementation and maintenance of ISO 13485 is provides consistency and repeatability of the devices and related services provided by the organization.
• ISO 13485 is focuses on processes used to develop medical devices and services.
• Helps organization to comply with relevant product oriented regulations.
• ISO 13485:2016 is based on ISO 9001:2015 and can be easily integrated to existing QMS.
• ISO 13485 also focus more on how procedures regulate and control activities and process performance

 Participants of our training courses learn:

•  Effective implementation of an MDQMS
• Benefits of ‘Process Approach’ in implementation of  ISO 13485:2016
• The purpose and intent of the ISO 13485 standard
• To integrate the processes and implement checks and balances
• To integrate ISO 9001 and ISO 13485 standards into one system
• The relationship of ISO 14971and ISO/TR 14969 with ISO 13485:2016
• To apply standard’s clauses and intent to the manufacturing system
• To relate key elements of the standard to business policy and objectives

Why ISO 13485 Conformance is Important?

• Stepping stone for CE marking and international markets
• A system that meet FDA 21 CFR Part 820 (Quality System Regulations)
• Essential step in obtaining permission to sell in the European Union

Why using BDSi?

• Over 35 years of expertise in helping organizations
• Over 20 different international standards
• Experienced consultants with practical knowledge
• Customized Business Systems approach to meet your business needs
• Our consultants and trainers are well known in the industry
• A system that will compliment the organization’s business practices.

ISO 13485:2003 Series Training

• ISO 13485 Internal Auditor Training
• ISO 13485 Internal Lead Auditor Training
• Role of Top Management (Executive Overview)
• Understanding and Implementing ISO 13485
• Integrating ISO 9001 and ISO 13485

For more information or to schedule a training session please contact