Seminar on Medical Devices - ISO 13485

A detailed look at each section of the standard.

Real world examples of what to expect, and what to prepare and repeal within the audit guidelines.

What must a documentation system look and feel like to ensure compliance?

These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO Certification 13485 is within your grasp.

Clean rooms 101, we can assist in what to do and what not to do. From the infrastructure, to the maintenance, PPE, etc. It is a holistic system that must be maintained at optimal standards at all times.

How is the quality within the organization? Materials must be accounted for and properly maintained. Only the highest quality materials should be utilized to create a unique and durable product.

Your suppliers must be chosen carefully. Ensure that each vendor is vetted and reviewed at least annually. The product you are making cannot be at or maintain any level of quality unless the supply chain is acceptable and consistent.

A true and complete internal audit is key to ongoing certification. The system must be looked at entirely each year, and by independent parties to validate that each section of the standard is being met, and is consistently documented to be functional. Who should audit which section, what type of documentation must be kept; this will be reviewed and explained.