Our Medical Device Compliance Consultants are ready to help make sure that your medical devices and processes meet domestic and international regulatory compliance standards.
Medical device compliance is governed by regulations that are similar, but not identical too regulations for pharmaceutical products. Like pharmaceutical products, medical device compliance requirements have some variation, depending on each government’s requirements. In the U.S., medical device compliance is governed (primarily) by the Title 21 Code of Federal Regulations, Part 820, known as the Quality Systems Regulation, or 21 CFR 820, QSR, for short.
The QSR is less prescriptive than the pharmaceutical GMPs because there is so much variability in a medical device. Therefore, the regulation incorporates flexibility, to allow the manufacturer to adjust the requirements, based on the risk profile of the device. This is accomplished in two ways.
First, devices receive a classification, which also maps to a Product Code. The classification (Class I through Class III) identifies the risk level of the device, with Class I being the least prone to risk (example: tongue depressor—KBL) and Class II being the highest risk (example: cardiac stent—MAF). Specific types of devices are identified by their three-character Product Code, and the FDA provides consensus standards associated with each product code.
Furthermore, many devices, especially the novel ones that do not yet have a product code, require Design Control to establish that the design of the device results in a product that is suitable for its intended use. Poor product design is often the results of skipping an essential element of Design Control. Many Class I devices and some Class II device product codes are exempt from Design control if the technology is well understood.
Controls over the design of the medical device is only the beginning. The second element of the Quality System Regulation is a functionally integrated Quality Management System that assures that all materials, systems, and processes are controlled to manage all aspects of medical device production, from raw material receipt all the way to installation and servicing of the device, and resolution of customer complaints. The QSR requires records to demonstrate that management is accountable for providing resources for and making decisions affecting, product quality.
There are seven major quality subsystems that are assessed in an FDA medical device site inspection, according to the FDA’s QSIT manual:
- Management Responsibility
- Design Control
- Corrective and Preventive Action (CAPA)
- Facility and Equipment Control
- Material Control
- Procedures/Documents Change Control
- Production and Process Controls
A QSIT (Quality Systems Inspection Technique) audit is expected to cover Management Responsibility, and a preponderance of the other six quality subsystems. Firms found in substantial compliance are often prepared with an understanding of the types of questions the investigator will ask about the above quality subsystems, and will have documented evidence showing that materials, systems, and processes were design and implemented in a manner that meets the requirements of 21 CFR 820.
Part 820 is only a U.S. standard, and worldwide standards exist for other jurisdictions. For example, Health Canada has a set of requirements, Japan has its PDMA, Brazil ANVISA. Fortunately, a certification exists to show that an organization is harmonized to multiple worldwide medical device standards, called MDSAP: The Medical Device Single Audit Program. Obtaining an MDSAP certification helps medical device establishments to get a single audit to cover multiple worldwide regulatory jurisdictions. Furthermore, the ISO certification to ISO 13485 is also recognized internationally.
How can CT’s Medical Device Compliance Consultants help you?
Contact us for a medical device compliance gap assessment to ensure that your organization is ready for an audit or regulatory inspection.
After initial assessment, Compliance Team’s experts can help to formulate a plan to address the compliance gaps, assist your organization in implementing solutions, provide training, and can coach you through the actual audit or inspection.