Medical Device Audits for Manufacturers

What is a Medical Device Audit?

A medical device audit is an inspection done to ensure that both regulatory and industry requirements are met. Device manufacturers can initiate the audit internally or it may be conducted by a second party such as QA Consulting. An external audit is performed by a regulatory agency such as the FDA in the United States or a qualified Notified Body in Europe. The audit may focus on the medical device manufacturer themselves, or the manufacturer’s supplier(s) (if separate from the manufacturer).

Medical device audits are conducted on-site or virtually. The process involves a review of all documentation, interviews with employees, and an in-depth tour of the facilities. The goal is to inspect all aspects of the design, manufacturing and post-release processes, from ensuring the proper regulatory documentation is in place to reviewing the performance of the device.

Are you preparing for an FDA inspection? Not sure where to start?

What is an Internal Audit?

A medical device internal audit can be conducted within a medical device manufacturer’s own company, provided the employees performing the audit are not part of a 3rd party or directly involved in the processes being audited. An outside consulting agency such as ours is often chosen because our knowledgeable experts understand current regulatory and industry requirements, and can guarantee a thorough audit that highlights any issues that must be addressed.

ISO 13485 and FDA 21 CFR Part 820 require Class II and III medical device manufacturers to perform internal audits. These policies necessitate that audits verify all procedures are compliant. Manufacturers must have SOPs (standard operating procedures) in place for such audits and maintain detailed documentation of audit results.

Mock Audits

A mock audit is another form of medical device internal audit. It is conducted to teach manufacturers about the auditing process, and provide valuable experience — especially for newer companies.

During mock audits, a team of experts will introduce your company to the ins and outs of medical device auditing. This serves as a way to get your company comfortable with auditing in a low-stress, practice scenario.

What is a Supplier Audit?

It is common for medical device manufacturers to outsource premarket requirements. Companies outsource a range of processes from packaging to testing the functionality of electronic components.

As the manufacturer, the responsibility falls on your company to ensure compliance, even if you use external suppliers. A supplier audit ensures compliance across all parties. This is especially important if your company uses risky materials. For example, sensitive electronic components are a riskier supply than cardboard boxes and may require a more detailed audit.

Enlisting the help of an outside agency gives you the knowledge and experience needed to ensure compliance. This is exactly what QA Consulting provides.

What are Product and Process Audits?

Product and process audits are also known as regulatory audits. In the United States, this means the FDA will conduct the medical device audit, while in Europe the EU MDR (European Union Medical Device Regulation) is involved.

These audits can be conducted as a routine inspection, as a way to receive certification or approval, or “for cause”. The “for cause” audits are naturally the most anxiety inducing as they indicate an issue and potential noncompliance. However, such audits do not have to be a horrible experience with employees scrambling to prepare for a serious on-site visit. When you work with QA Consulting, we’ll pair you with an expert consultant who is trained in the particular products and procedures being audited. Our knowledgeable consultants give you a specialized and effective partner throughout the audit.

What is the MDSAP Program?

MDSAP stands for the Medical Device Single Audit Program. The program rolls multiple audits into one. Manufacturers can get approval for markets in five countries: Australia, Brazil, Canada, Japan, and the United States.
This is a great choice for those who wish to market their medical device internationally. However, it comes with a host of regulatory requirements and stipulations manufacturers must meet to gain approval. In order to participate in the MDSAP, manufacturers must use a recognized Auditing Organization, a process we can assist with.

Medical device regulations are evolving. These rapid changes can cause headaches for medical device companies. That’s why we’ve made it a priority to help clients navigate and understand this changing regulatory landscape. Are you ready to adapt and thrive?

Key Points

QA Consulting is Here to Help

Medical device manufacturers exist to innovate and provide the market with helpful and safe devices. Compliance plays a key part in achieving these ends. Without it, devices would not be deemed secure enough to go to market in the first place.

Manufacturers don’t need to become experts in evolving regulatory, quality, and industry requirements. Just like outsourcing to suppliers, it makes sense to outsource to regulatory and quality systems experts who understand the nuances of the auditing process.

At QA Consulting, we match companies like yours with consultants that have a firm grasp on your specific medical device and audit type, whether that is a mock audit or a “for cause” FDA visit. To bring competitive experience and certification to the table, we only send Certified Auditors (ASQ CQA), ISO 13485 QMS Lead Auditors or Subject Matter Experts to Client facilities for audits.