When should Medical Device Internal Audits be Conducted?

by Kris Kelly · Published December 18, 2023 · Updated December 19, 2023

When should medical device internal audits be conducted? The timing of audits in a medical device development and manufacturing company can vary based on several factors.

By John Rodriguez

Medical device internal audits can be stressful for developers and manufacturers; knowing when (and how) to execute can bring you peace of mind.

Do you already have a regular schedule for conducting audits? Your audits may already be part of an established schedule. This schedule could be quarterly, semi-annually, or annually, depending on the company’s policies and regulatory requirements. If this is the case, it is simple. Follow your established schedule.

What if you do not have an established schedule and you have just introduced a new product, or you are getting ready to release your first product to manufacturing. Audits conducted prior to manufacturing or after a new product introduction ensure that each stage of the process meets regulatory and quality standards and help maintain ongoing quality control and identify deviations from established procedures. Conducting an audit is critical at this stage and prepares you for potential upcoming certifications.

In summary, the best time to conduct an audit depends on the specific context, regulatory requirements, and the company’s internal policies. A combination of scheduled routine audits (and targeted audits in response to specific events or milestones) is often the most effective approach.

Is it critical that we conduct the audit?

Audits are crucial in a medical device organization; they help to identify areas of concern in Regulatory Compliance, Quality Assurance, Risk Management, Process Improvement, Supplier Evaluation, Documentation Review, Customer Confidence, and Legal Compliance.

For many start-up device manufacturers, having an outside organization conduct an audit seems like a waste of time and money. This is not the case! Companies that have this perception need to understand the value of an unbiased review of their documentation and how it serves as insurance for the company.

Regular audits are part of an initiative-taking approach to quality management. They enable continuous monitoring of processes, allowing companies to address issues promptly and prevent potential non-compliance or quality problems. Audits play a crucial role in ensuring that medical device development and manufacturing companies adhere to regulatory standards, maintain high-quality standards, and continuously improve their processes to deliver safe and effective medical devices.

Wait, we are a small company and we’re just starting out. Do we really need an outside organization to conduct an audit?

The decision of whether to conduct internal audits with an in-house team or hiring an outside organization depends on several factors, and there is no one-size-fits-all answer. Both approaches have their advantages and considerations. When should medical device internal audits be conducted? Let’s try asking Who should conduct the audit.

Here are some factors to consider when deciding whether an internal audit is best conducted by an in-house team or an outside organization:

An in-house team immediately understands the product, processes, culture, and existing challenges where an outside organization could not immediately understand this.
- On the other hand, the internal team may overlook items because of their internal knowledge; yes, we have known about that for years, but engineering is taking care of it.
External auditors bring an independent and objective perspective to the audit process. This can be beneficial for identifying issues that may be overlooked by internal staff due to their familiarity with internal processes.
- Hiring an external organization provides flexibility in terms of resources. Organizations can engage external auditors for specific projects or audits without the need to distract your engineering, regulatory or compliance team from on-going critical activities.

The decision of selecting an outside organization or collaborating with your internal team should align with the organization’s goals, resources, and the level of independence and expertise required for effective audits.

Here’s what can happen if you don’t conduct internal audits.

One client contacted us and requested assistance, after their FDA submittal was rejected (twice) due to their intended use validation (IUV) program being non-compliant (a tool validation was missing) which they would’ve discovered during an internal audit. 😎

Advantu’s team performed a gap analysis, discovered the risks and (per client request) performed all the corrective actions to completion. We supported updating the submittal, (it was sent a final time), and it was successfully accepted by the FDA.

Advantu is here for you to address all your compliance, development, and manufacturing needs.