ISO 13485 > FAQ

The FDA is responsible for protecting the public health by assuring the efficacy, safety, and security of food, drugs, biologicals, medical devices, animal feed and drugs, cosmetics, and products that emit radiation.

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating companies that manufacture, repackage, relabel, perform specified processes, and/or import medical devices sold in the United States.

Foreign establishments that export devices into the United States are also required to list their devices with the FDA and are subject to on-site inspections. The CDRH also regulates radiation-emitting electronic products (both medical and nonmedical) such as lasers, X-ray systems, and ultrasound equipment.

The FDA classifies medical devices into three regulatory categories—class I, II, and III—each of which depends on the level of regulatory control necessary to assure safety and efficacy.

• Class I devices are subject to minimal requirements, including good manufacturing practice (GMP) and other general controls.
• Class II devices must comply not only with general controls but also with any applicable performance standards developed to assure safety and efficacy.
• Class III devices are subject to premarket approval in addition to general controls; generally these are life-sustaining or life-supporting devices such as implants.

You can read more about device classification and link to the Product Classification Database by visiting the FDA official government website: http://www.fda.gov/cdrh/devadvice/313.html.

There are basic regulatory requirements with which manufacturers of medical devices distributed in the United States must comply. They include:

• Submitting a premarket notification 510(k), unless exempt, or premarket approval (PMA)
• Registering establishments with the FDA
• Achieving a medical device listing by the FDA
• Complying with the quality system (QS) regulations
• Meeting labeling requirements, including directions for use
• Maintaining complaint records and follow-up investigations, as well as adhering to the medical device reporting (MDR) process

No. Compliance with FDA regulations goes a long way toward preparing your organization to meet the ISO quality system standard for medical devices, namely, ISO 13485. However, for organizations distributing medical devices in the United States, whereas ISO conformance is voluntary, FDA regulations are law and take precedence. There are differences between the regulations and the standard that are significant enough to require independent attention. For example, ISO 13485 requires continual improvement as a formal process, whereas the FDA has no such requirement. These differences remain despite significant activity in North America, Europe, Japan, and other countries toward harmonizing standards and regulations governing medical devices.

As a recognized leader in FDA compliance, Oriel STAT A MATRIX has been involved in this type of training and consulting for many years. Although our work with each client remains strictly confidential, the strategies and tactics we have developed can provide your organization with the guidance, understanding, and tools you need to effectively and efficiently achieve FDA compliance and ISO conformity. In fact, the Oriel STAT A MATRIX 14-step implementation process is applicable to companies seeking compliance with the FDA's Medical Device Quality System Regulation as well as ISO 13485 registration.

Oriel STAT A MATRIX has programs and consulting capabilities to help guide all types of organizations through the often overwhelming maze of regulatory compliance and standard certification requirements. 

Our highly experienced consultants—most of whom have been through this process in the corporate world themselves—understand and address individual needs within small and large organizations. 

Oriel STAT A MATRIX works with Fortune 500 companies to sharpen skills and capabilities, providing experts in specific subject areas as needed, as well as to educate and inform their new employees. Likewise, Oriel STAT A MATRIX works with start-up companies to jump-start their programs and cost-effectively address new initiatives.

The FDA's Center for Devices and Radiological Health (CDRH) has created cross-cutting collaborative product groups to better integrate premarket, postmarket, and enforcement efforts.

The CDRH is pursuing the development of unique identifiers (UDI) for medical devices, in collaboration with industry and health care providers, in order to easily identify specific devices when postmarket questions are raised. The CDRH also is considering making electronic reporting of adverse event data mandatory ("eMDR").

Oriel STAT A MATRIX is continually involved in the development and interpretation of regulations facing the medical device industry. The FDA continually reviews its programs and annually publishes new regulatory initiatives and goals based on its oversight experience and congressional input.

Staying linked to Oriel STAT A MATRIX programs and consultants is an effective means of staying on top of the ever-changing regulatory environment.

There have been several changes to the FDA's inspection approach. One important area for device manufacturers to better understand is the quality system inspection technique (QSIT) for evaluating device manufacturers’ compliance.

QSIT is a “top-down” approach that focuses on key control elements or subsystems of the regulations, including management controls, design controls, corrective and preventive actions (CAPAs), and process controls. Understanding this inspectional technique can help you determine the best approach to compliance for your organization. Oriel STAT A MATRIX has the experience and resources to guide you in this area.

Awareness is growing in the medical device industry that organizations not only need to know how to comply with regulations and standards, but also how to integrate the regulations and standards into value-added business processes.

To that end, Oriel STAT A MATRIX provides guidance in designing customized processes and compliance pathways, which support your business goals. For instance, we emphasize process models that link the compliance/conformance needs with business activity-interface management and control systems.  Another strategy is tying together the various elements of a robust quality management system with the methods to monitor, control, and sustain those elements.  And still another approach is to align problem solving and project management linked to compliance activities.

Oriel STAT A MATRIX offerings are comprehensive and robust. They include—but are not limited to—programs in the following areas:

• The FDA’s medical device regulations
• The FDA’s quality system inspection techniques
• Process and software validation
• Risk management and analysis
• Design control and management
• ISO 13485 Implementation
• ISO 13485 and ISO 9001 internal and leader auditor certification training
• Corrective and preventive actions (CAPAs) for the medical device industry

Customized consulting services, auditing, and documentation review are also available to meet the specific needs of your organization.