Parts of the FDA Medical Device Audit Checklist

Controls to Assure Appropriate Market Authorization
Confirm that your medical device organization has established and documented controls to ensure devices with appropriate marketing clearance or approval are distributed or offered for distribution into participating MDSAP jurisdictions, this may involve cross-referencing distribution records and service reports with lists of valid marketing authorizations.

Design and Development
Design and development should be one of the focal points of your audit checklist, since this section often connects to multiple sections or items; for example, if your product features software development processes that must be well documented and validated.

Your SMEs must also be prepared to respond to questions from inspectors regarding the design and development process as well as steps taken to validate and transfer this design into production.

An effective strategy to help reduce audit stress for everyone involved would be for your SMEs to participate in mock FDA inspections, practicing answering investigators’ queries in advance. This will build their confidence when facing inspectors directly, and make the audit process far less daunting for all.

Manufacturing
One of the key components of an FDA medical device audit involves reviewing documentation related to manufacturing processes. This process entails verifying that all devices meet with Essential Principles established by the Center for Devices and Radiological Health – these principles aim at ensuring medical devices remain safe and effective from product launch onward.

Manufacturers must also implement and document an integrated hazard analysis and control system, which should include keeping an up-to-date Documented Hazards Register (DHR), Process Validation Report, Sterilization Records and Training Certification Records of their staff members.

Subject Matter Experts (SMEs) should also be prepared for an FDA inspection by practicing mock investigator interviews and being familiar with all appropriate protocols like CAPA, complaint handling, acceptance activities and purchasing controls – this can often be accomplished with the aid of a quality management solution that includes audit management workflows.

Quality Control
The FDA regularly conducts inspections to ensure that devices produced by manufacturers comply with FDA regulations, before being sold on the national market. This ensures the protection of public health by assuring any medical device, drug or vaccine produced or sold is suitable for human consumption.

Medical device companies that want to prepare themselves for FDA inspection should conduct thorough yet manageable internal audits of their quality assurance systems. An internal audit should cover various areas such as these.

An integral aspect of preparation for an FDA inspection is making sure your Subject Matter Experts (SMEs) know how to respond to any inquiries from investigators, so it is wise to practice answering questions by simulating investigator interviews. Furthermore, all SMEs should remain honest and professional at all times.

Regulatory Compliance
Medical device industry companies must comply with FDA standards in order to remain profitable and safeguard patient safety, which may mean inspections. Failing to do so could result in product recalls or removal from market which could impact both profits and patient safety negatively.

At an inspection, FDA inspectors will want to see documentation regarding the design, testing, manufacturing, labeling and storage of medical devices. Furthermore, they’ll want to see that change control processes are in place as any changes made without your knowledge could create noncompliance issues that jeopardise patient safety.

Therefore, it’s essential that your company understands which medical device code it falls under in order to maximize your chances of market entry in the US. Learn more about what medical device classes are here; knowing your medical device class will save time and money in terms of submissions, inspections, recalls etc.