This standard will bring about substantial benefits as it:

  • Ensures compliance with customer and regulatory requirements
  • Promotes enhanced product safety and effectiveness through continuous improvements
  • Represents an accepted approach to quality management by regulators in the industry

ISO 13485:2016 specifies requirements for a quality management system to ensure compliance with appropriate standards and impacts companies involved in any stage of the medical device life cycle, including:

  • Design
  • Development
  • Production
  • Storage
  • Distribution
  • Installation
  • Servicing

This new standard carries many new requirements. A high-level summary of 5 of the key changes included within ISO 13485:2016 is below:

1. Risk-Based Approach: There will be a much stronger emphasis on a risk-based approach throughout your entire quality management system. Additionally, all processes comprising the quality management system, including any that have been outsourced to third parties, will need to be developed utilizing a documented, risk-based methodology.

2. Documentation of Skills and Training: Any individual involved with your quality management system will need to have their skills and experience levels thoroughly documented. There will also be an enhanced focus on your ongoing training efforts and the assessment of the effectiveness of your training methods.

3. Complaint handling: You will now need to develop and document specific complaint handling procedures for all complaints, not just the ones filed by customers. Additionally, the procedures must also address the need to report complaints to the appropriate regulatory authorities as well as the implementation of appropriate corrective actions.

4. Supplier Monitoring: You must take your evaluation of your suppliers further and continuously monitor their performance levels and conduct appropriate re-evaluations of their performance as well. You must also now document the impact and risk posed to your organization from an underperforming supplier.

5. Design and Development: ISO 13485:2016 now includes specific details on how an organization should control changes in design and development. All personnel must now assess the impact of these new changes and keep all documentation on file. There are also new validation and verification requirements you will need follow for your design and development efforts, including when transferring a medical device from design and development to production.

While companies do not need to implement ISO 13485:2016 until February 2019, quality and regulatory professionals should not delay their assessment of ISO 13485:2016’s impact and should begin the implementation process now.

Our Free 30 Minute Consultation

We are currently offering a Free 30 Minute Consultation to help you navigate ISO 13485:2016. To schedule your Free 30 Minute Consultation, just fill out the form, and one of our team members will be in touch to set up your meeting.

Don’t wait to schedule your Free 30 Minute Consultation! This service is only available for a limited time.

Are you ready for these Major Medical Device Changes? Let us help you find out!

Let PRP provide the guidance you need on what to expect. Our subject matter experts can help you navigate these changes by sharing how other medical device companies are approaching these challenges. To schedule your Free 30 Minute Consultation, just fill out the form. One of our Client Service Managers will be in touch to schedule a 10-minute call to discuss how we are helping our clients with these issues as well as to set up your 30 Minute Consultation.

Don’t wait to schedule your Free 30 Minute Consultation! This service is only available for a limited time.