After the quieter holiday period, many organisations are now fully back at work. With that return often comes a familiar reality for medical device manufacturers: internal audits to plan and complete, and notified body audits on the horizon.
This is a natural point in the year where quality and regulatory teams take stock. Documentation is revisited, processes are tested, and readiness for external scrutiny becomes a priority. It is also an ideal moment to use internal audits not just as a regulatory obligation, but as a practical tool to strengthen your Quality Management System (QMS) and technical documentation.
At MDS, we are seeing a clear increase in audit activity across our client base, and internal audits are often the most effective first step in preparing for what comes next.
Internal audits are more than a regulatory requirement
Internal audits are, of course, a formal requirement under standards such as ISO 13485 and a key expectation under the EU MDR and IVDR. However, when approached correctly, they offer far more value than simple compliance.
A well-executed internal audit provides an independent, structured view of how your QMS and technical files function in practice. It helps confirm what is working well, highlights areas that need attention, and creates a controlled opportunity to address gaps before they are identified by a notified body or competent authority.
Rather than being a box-ticking exercise, internal audits can act as a strategic health check for your organisation.
Preparing for notified body audits with fewer surprises
Notified body audits are increasingly detailed, risk-based, and documentation-driven. Expectations around traceability, consistency, and lifecycle thinking continue to grow, particularly under MDR and IVDR.
Internal audits allow organisations to test their readiness under realistic conditions. They help identify issues related to document control, risk management, clinical evaluation, post-market surveillance, and process implementation while there is still time to act.
Addressing findings internally is significantly more manageable than responding to non-conformities raised during an external audit. It also supports more confident, structured interactions with notified bodies.
What an effective internal audit should cover
An internal audit should provide a holistic view of your system, not just isolated checks. At MDS, our audits are designed to assess both compliance and effectiveness, with a focus on real-world application.
Our auditing services include:
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Comprehensive QMS audits, covering standards such as ISO 13485, as well as related frameworks including ISO 9001, ISO 14001, ISO 27001, ISO 15189, and IEC 62304. Where relevant, we also consider FDA expectations such as QSR or MDSAP.
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Technical file reviews, assessing alignment with EU MDR and IVDR requirements across device description, risk management, clinical evaluation, and post-market documentation.
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Gap analysis, identifying areas where your system or documentation does not fully meet regulatory expectations.
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Corrective action planning, with practical support in defining and implementing remediation activities.
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Continuous improvement focus, using audit outcomes to strengthen processes over time, not just close findings.
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Employee engagement and training, involving teams at different levels to improve understanding and ownership of quality and regulatory requirements.
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Follow-up and support, ensuring corrective actions are implemented and sustained.
Why working with an external audit partner adds value
While internal audits can be conducted in-house, an external perspective often brings added clarity. An independent auditor can identify issues that may be overlooked internally and provide insight based on current regulatory practice and notified body expectations.
At MDS, our auditors bring deep experience across medical device regulations and quality management systems. We tailor each audit to the size, maturity, and complexity of the organisation, ensuring that findings are relevant, actionable, and proportionate.
Our goal is not only to confirm compliance, but to help clients build robust, resilient systems that stand up to regulatory scrutiny and support long-term success.
Getting ahead of the audit season
As audit schedules fill up and notified body availability remains limited, early preparation makes a tangible difference. Internal audits carried out at the right time can reduce pressure, improve outcomes, and support smoother external assessments. If you are planning internal audits or preparing for an upcoming notified body audit, now is a good moment to act.
MDS supports medical device manufacturers with internal audits, technical file reviews, and audit preparation under ISO standards, MDR, and IVDR. We work closely with your team to ensure clarity, confidence, and readiness. Contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
