
Clinical Evaluation Report: EU MDR Requirements
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Home » Services » Quality System Management » ISO/IEC 27001 Internal Auditing Services
Our ISO 27001 Internal Auditing services support organisations in maintaining compliance with ISO/IEC 27001 and ensuring the effectiveness of their Information Security Management System (ISMS). Patient Guard provides independent, expert audits to help you identify gaps, reduce risks, and achieve certification readiness.
Organisations implementing or maintaining ISO/IEC 27001 must conduct regular internal audits to ensure their Information Security Management System (ISMS) remains effective and compliant with the standard.
Internal audits are a mandatory requirement under ISO 27001 and play a critical role in identifying nonconformities, assessing risk controls, and ensuring continuous improvement.
Patient Guard provides professional ISO 27001 internal auditing services, offering an independent and objective review of your ISMS against ISO/IEC 27001 requirements.
We help organisations prepare for certification audits, maintain compliance, and strengthen their information security controls.
Whether you are preparing for initial certification or ongoing surveillance audits, we ensure your ISMS is audit-ready and aligned with best practices.
We have extensive experience supporting organisations with ISO standards and compliance frameworks.
We support start-ups, SMEs and global organisations across a range of industries.
Our audits provide unbiased insights to improve your ISMS performance and compliance.
Clear project-based or fixed pricing with no hidden costs.
We deliver detailed audit reports with practical recommendations for improvement.
We can conduct audits remotely, on-site, or through a hybrid approach depending on your needs.
Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.”
Tracey Slater, Cormed
We conduct comprehensive audits of your ISMS against ISO/IEC 27001 requirements.
We evaluate the effectiveness of your information security controls and risk management processes.
We review policies, procedures, and records to ensure compliance with ISO 27001 requirements.
We identify gaps, nonconformities, and areas for improvement within your ISMS.
We provide a detailed audit report with clear findings and corrective action recommendations.
We support corrective actions and re-audits to ensure ongoing compliance.
We conduct mock audits to prepare for certification or surveillance audits.
ISO/IEC 27001 requires organisations to conduct internal audits at planned intervals to ensure that the ISMS:
Internal audits must be independent, documented, and conducted by competent personnel.
We define scope, schedule, and audit objectives.
We conduct the audit, including interviews, document review, and process assessment.
We provide a detailed audit report with findings and recommendations.
We assess all key areas of your ISMS, including:
From
Ensure ongoing compliance and certification readiness with expert ISO 27001 quality audits.
1-4 weeks
5-9 days depending on organisation size
2-4 days depending on organisation size
An ISO 27001 internal audit is a systematic review of an organisation’s Information Security Management System to ensure compliance with ISO/IEC 27001 and identify areas for improvement.
Yes, internal audits are a mandatory requirement under ISO/IEC 27001 and must be conducted at planned intervals.
Yes, many organisations outsource internal audits to ensure independence, objectivity, and access to experienced auditors.
Internal audits should be conducted at planned intervals, typically annually, depending on the size and complexity of the organisation.
The duration depends on the size and complexity of your ISMS but typically ranges from 5–9 days.
Click on the links below to discover more:

Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.

Medical device labelling is more than a packaging exercise. It is a regulatory requirement that communicates essential information about a device’s identity, safety, and intended use.

Regulatory approval is not the end of scrutiny, it is the beginning of structured data collection.

If you are implementing a medical device QMS, preparing for certification, or recovering from audit findings, understanding ISO 13485:2016 requirements is non-negotiable.

2026 represents a significant milestone for the amended IVDR transitional provisions framework.

If you sell cosmetics in the UK or EU, you are legally required to maintain a Cosmetics Product Information File – even if you’re a tiny indie brand mixing batches between client emails.
Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
UK Office
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
Thank you! The checklist is now ready to download.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office