
Clinical Evaluation Report: EU MDR Requirements
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Our ISO/IEC 27001 implementation services support organisations in developing, implementing, and achieving certification to ISO/IEC 27001:2022. Patient Guard provides expert guidance to ensure your Information Security Management System (ISMS) is compliant, secure, and aligned with your business risks.
ISO/IEC 27001 is the internationally recognised standard for Information Security Management Systems (ISMS), designed to help organisations protect sensitive information, manage cyber risks, and ensure data security.
Achieving ISO/IEC 27001 certification requires a structured approach to risk management, information security controls, and continuous improvement.
Patient Guard acts as your ISO 27001 consultancy partner, guiding you through the full implementation process—from gap analysis to certification—ensuring a secure and efficient route to compliance.
Without a structured ISMS, organisations face increased risks of data breaches, regulatory penalties, and reputational damage.
Patient Guard provides expert ISO/IEC 27001 implementation services for organisations across all industries. We support risk assessments, documentation development, internal audits, and certification readiness.
Whether implementing ISO 27001 for the first time or transitioning to the latest version, we ensure a streamlined and compliant approach.
We have extensive experience supporting organisations with ISO standards and compliance systems.
We support start-ups, SMEs, and global organisations across multiple sectors.
We design ISMS solutions that are both compliant and tailored to your business risks.
Clear project-based or fixed pricing with no hidden costs.
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 assess your current controls against ISO/IEC 27001 requirements to identify gaps.
We develop policies, procedures, and records aligned with ISO/IEC 27001:2022.
We identify information security risks and implement appropriate controls.
We define and justify applicable security controls based on your risk profile.
We establish and conduct internal audits to verify ISMS effectiveness.
We guide leadership through ISMS performance review and compliance.
We prepare your organisation for Stage 1 and Stage 2 certification audits.
ISO/IEC 27001:2022 requires organisations to establish an Information Security Management System based on:
A compliant ISMS ensures confidentiality, integrity, and availability of information across the organisation.
We assess your organisation, assets, and security risks
We identify areas requiring development to meet ISO/IEC 27001 requirements
We build your ISMS, including policies, procedures, and controls
We support rollout and train your team on security practices
We prepare you for certification audits and ongoing compliance
We support ISO/IEC 27001 implementation across a wide range of industries, including:
From
Ensure quality compliance and certification readiness with expert ISO/IEC 27001 implementation support. Pricing starts from £6,750 for a basic implementation.
Assess current controls, identify gaps, and define your ISMS scope and risk profile
Develop policies, procedures, risk treatment plan, and implement security controls
Conduct internal audits, management review, and prepare for Stage 1 and Stage 2 certification audits
Implementation typically takes between 6–16 weeks, depending on the size and complexity of your organisation
ISO/IEC 27001 is an international standard for Information Security Management Systems (ISMS), helping organisations protect sensitive information and manage cybersecurity risks.
Implementation typically takes between 6–16 weeks depending on the size, complexity, and existing controls within the organisation.
IISO 27001 certification is often required for contracts, data security assurance, and regulatory compliance, particularly for organisations handling sensitive data.
The SoA defines which security controls are applicable to your organisation and justifies their inclusion or exclusion based on risk.
Costs vary depending on organisation size and scope, but we offer transparent pricing tailored to your requirements.
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