Overview

Welcome to the exciting world of medical devices, especially those manufactured or marketed in the United States and its territories. If you're new to the medical device market, or simply new to the US market, this course is perfect for you. Even if you're a seasoned quality management veteran, there may be elements of the Quality System Regulations (QSR) that you don't fully understand or know how to implement effectively. Therefore, this course is designed to cater to all these cases. While all quality people in the medical device industry know these regulations, only the great ones truly understand them.

Managing the CAPA process is a critical aspect of maintaining quality standards in medical device companies. Orcanos provides a reliable system to manage CAPA processes and relevant actions. As per the FDA's regulations, medical device companies must analyze quality audit reports, work operations, returned products, service records, concessions, processes, and other quality data sources to identify the root causes of non-conforming products. Once the causes are determined, the companies must formulate solutions, verify or validate them, implement necessary changes, and report them for management review. Orcanos' CAPA process ensures that medical device companies manage risk effectively throughout the product life cycle.

The ISO 13485:2016 standards distinguish between Corrective and Preventive Actions. Corrective Actions (section 8.5.2) require organizations to take prompt and appropriate measures to eliminate the root cause of nonconformities to prevent their recurrence. Preventive Actions (section 8.5.3) require organizations to identify and address potential nonconformities before they occur. The corrective and preventive actions taken must be proportionate to the impact of the nonconformities, whether actual or potential.

CAPA’s inputs and source possibilities are emphasized in the figure below.

> MAUDE stands for Manufacturer and User Facility Device Experience. It is a publicly accessible database maintained by the U.S. Food and Drug Administration (FDA) that houses medical device reports (MDRs) related to adverse events and product problems.

> VOC (Voice of the Customer) survey is a structured methodology used to capture the needs, expectations, and feedback of key stakeholders—such as clinicians, patients, and technicians.

> An NCMR (Nonconforming Material Report) is a formal document and process used in medical device manufacturing to identify, record, and manage materials, components, or finished products that fail to meet specified requirements.

Orcanos's recommended CAPA includes the following steps:

With the Orcanos system, you have the ability to initiate a CAPA, delve into its underlying cause, and determine which action to take next. You can opt to either include an action item (CPA work item) or link it to a complaint. The process concludes with a significant impact on the CAPA decision.

Read more in 57-page white paper was released on the #makeCAPAcool program during the MDIC Live session on May 2nd. The industry could benefit greatly from an 80% reduction in improvement implementation time. This improvement would improve product quality for patients and providers, aligning with the FDA’s CDRH mission.

ISO, ICH, and The FDA

We're going to look at the 21CFR820 regulations, but we will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Administration (FDA) guidance documents, as well as other standards in order to provide clarification on how 21CFR820 is interpreted and enforced.

We will also discuss some common mistakes and best practices and even discuss areas of current regulatory evolution.

The medical device industry is very challenging as the range of products and the basis of organizations that manufacture and market them is incredibly diverse.

While medical devices can span products that cover items such as:

• Tongue depressors
• Toothbrushes
• Sunglasses
• Scalpels
• Diagnostic test systems
• Magnetic Resonance Imaging (MRI) systems
• Medical lasers
• Drug eluding stents
  • Pacemakers
  • Mobile apps

The regulations that govern them are the same.

This, in part, is the reason the regulations can be difficult to interpret consistently, as an organization of 20 employees that develops a medical device app for a mobile device is likely to have very different systems in place when compared with an organization with 1,000 employees making a range of medical device products focused on the cardiovascular market.

This course will look at what is required and actually try to get down to a solid level of detail on how to implement these systems and note some areas where organizations may differ from one another but still comply with the same regulations.