Label Example

Device Labeling

Manufacturers are required to have labels for product and product labeling.  According to the FDA in section 201, a label is a “display of written, printed, or graphic matter upon the immediate container of any article” whereas “labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc.” 21 CFR 820 specifically…

Document Control

Document Control

Both FDA’s 21 CFR 820 and ISO 9001 have requirements for document control.  The goal with this section of the standards is to demonstrate that your quality system is compliant, that you design and manufacture products to meet design controls, and that your company is addressing risk management concerns.  The FDA typically takes the approach…

Business talk

Personnel Requirements

The FDA requires medical device manufacturers to have the appropriate personnel and training in place.  According to 21 CFR 820, “each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.”  Employees need to be trained so they can adequately…

Quality Policy Header

Quality Policy

Another item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy.  Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates.   This document…

Meeting Customer Requirements

Customer Requirements

As customers are the driving force behind any business, it makes sense to make sure they are taken care of.  Does your company have processes and/or procedures in place to identify your customer’s requirements?  For medical device companies, there are regulations in place from the FDA and ISO to make sure there are practices in…

Importance of Calibration

Why Calibration Matters

The concept of equipment calibration is an important one throughout FDA and ISO requirements.  ISO 9001, section 7.6 discusses it in a broad sense, while ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories”, is specifically about calibration.  In 21 CFR 820.72, it’s stated that “Calibration procedures shall include specific directions and…

Hammer

Preventive Maintenance

Preventive maintenance is a concept that includes care and servicing of equipment for the purpose of keeping equipment in a satisfactory operating condition.  It is designed to improve equipment life and avoid any unplanned maintenance activities.  This is accomplished through a systematic inspection, detection and correction of any developing failures before they occur.  Preventive maintenance…

Clean Room

Control of Equipment

As part of a company’s quality management system, there must be consideration for the equipment used within the facility.  According to the FDA’s 21 CFR 820, “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained.”  They also have the requirement that all inspection, measuring and test…

Network servers

Part 11 Compliance

As computer usage became more mainstream, especially as a way to store records, the FDA received a request from various industries for guidance on the use of electronic signatures and submissions to the FDA.  The FDA’s response to this request was to issue 21 CFR Part 11 in 1997, which covers electronic signatures, records and…