
Medical Device Regulatory Consulting Services Explained
Explore medical device regulatory consulting services for ISO, FDA, EU, and more. Build compliant systems, pass audits, and scale globally with expert support.
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.
Our lead consultants are BSI-qualified auditors who specialize in translating complex cyber landscapes into actionable business controls.
We uniquely blend information security with healthcare data protection protocols, aligning your ISMS perfectly with GDPR, MDR, and IVDR.
We avoid over-complicated policies. We design practical, lean security frameworks tailored entirely around your operational scale.
Since 2017, global companies have trusted our regulatory and quality assurance consultancy to safeguard their compliance.
We help you systematically apply Annex A security controls (from the latest standard revisions) to completely mitigate vulnerabilities.
We provide completely unbiased, audit-ready reviews ensuring your internal team, assets, and culture are set up to pass with confidence.
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
Defining the exact technical, physical, and organizational boundaries of your Information Security Management System.
Identifying potential vulnerabilities, predicting threats, and calculating risk probabilities across your entire infrastructure.
Selecting and mapping the appropriate security controls out of the 93 required methods to accurately treat identified risks.
Building clear, auditable access control policies, encryption standards, data classifications, and incident response procedures.
Deploying structured educational pathways to embed information security into your daily business processes and corporate culture.
Conducting full mandatory mock audits and compiling reporting metrics to guarantee your system is robust ahead of external review.
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
| Potential Risk | Without ISO 27001 | With ISO 27001 |
|---|---|---|
| NHS Procurement | Often barred from major tenders | Fast-track approval (DSPT alignment) |
| Data Breach Fines | Up to 4% of global turnover (GDPR) | Demonstrable 'Technical Measures' in place |
| Global Expansion | Multiple security audits per country | One internationally recognized certificate |
For medical device manufacturers supplying the NHS, ISO 27001 provides the rigorous framework needed to meet DSPT Category 1 and 2 requirements. We help you map your ISO 27001 controls directly to the DSPT, reducing duplication and ensuring your ‘Standards Met’ status.
We don’t treat Information Security in a vacuum. We align your ISMS risk assessments with your existing ISO 14971 medical device risk files. This ensures that cybersecurity risks (like data breaches) are considered alongside patient safety risks.
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:

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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.
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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.
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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.
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