ISO/IEC 27001 Implementation Services (Information Security Management Systems)

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.

500+ Manufacturers Supported
BSI ISO 13485 Certified
UK & EU Offices
Former MHRA Expertise
Established 2017
Patient Guard medical device regulatory consultancy illustration showing UKCA, CE MDR, FDA, ISO 13485, IVDR and technical documentation.

ISO/IEC 27001 Implementation Services

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.

Alex Lewis - Patient Guard - Quality Assurance Manager
"In the digital age of healthcare, data isn't just an asset—it’s a liability if not protected. We don’t just implement ISO 27001; we build a culture of cyber resilience that secures your intellectual property and patient data against evolving global threats."
Alex Lewis BSc, Qualifed Lead Auditor

Quality Assurance Manager

ISO 27001 implementation

Bespoke ISMS Implementation for HealthTech

Information Security Expertise

Our lead consultants are BSI-qualified auditors who specialize in translating complex cyber landscapes into actionable business controls.

Regulated Industry Specialism

We uniquely blend information security with healthcare data protection protocols, aligning your ISMS perfectly with GDPR, MDR, and IVDR.

Tailored Risk Management

We avoid over-complicated policies. We design practical, lean security frameworks tailored entirely around your operational scale.

Trusted by 500+ Companies

Since 2017, global companies have trusted our regulatory and quality assurance consultancy to safeguard their compliance.

Comprehensive Control Alignment

We help you systematically apply Annex A security controls (from the latest standard revisions) to completely mitigate vulnerabilities.

Independent & Objective Reviews

We provide completely unbiased, audit-ready reviews ensuring your internal team, assets, and culture are set up to pass with confidence.

patient guard

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

Leading Your ISO 27001 Stage 1 & 2 Audits

ISMS Scope & Strategy

Defining the exact technical, physical, and organizational boundaries of your Information Security Management System.

Security Risk Assessment

Identifying potential vulnerabilities, predicting threats, and calculating risk probabilities across your entire infrastructure.

Annex A Control Selection

Selecting and mapping the appropriate security controls out of the 93 required methods to accurately treat identified risks.

Policy Framework Drafting

Building clear, auditable access control policies, encryption standards, data classifications, and incident response procedures.

Staff Training & Culture

Deploying structured educational pathways to embed information security into your daily business processes and corporate culture.

Pre-Certification Internal Audit

Conducting full mandatory mock audits and compiling reporting metrics to guarantee your system is robust ahead of external review.

Who Requires ISO/IEC 27001 Implementation?

ISO/IEC 27001 Requirements Overview

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.

Our Process

01

Initial consultation

We assess your organisation, assets, and security risks

02

Gap analysis

We identify areas requiring development to meet ISO/IEC 27001 requirements

03

ISMS development

We build your ISMS, including policies, procedures, and controls

04

Implementation and training

We support rollout and train your team on security practices

05

Internal audit and certification support

We prepare you for certification audits and ongoing compliance

ISO 27001 information security management system

Industries We Support

We support ISO/IEC 27001 implementation across a wide range of industries, including:

Cost of Service

Premium

ISO/IEC 27001 Information Security Management System

£ 6,750

From

Ensure quality compliance and certification readiness with expert ISO/IEC 27001 implementation support. Pricing starts from £6,750 for a basic implementation.

Features

  • Full ISO/IEC 27001:2022 compliant ISMS development tailored to your business
  • Gap analysis and implementation roadmap for fast certification readiness
  • Internal audit and management review support
  • End-to-end certification support including Stage 1 and Stage 2 audit preparation

Time Lines

01

Weeks 1–3 – Gap Analysis & Risk Assessment

Assess current controls, identify gaps, and define your ISMS scope and risk profile

02

Weeks 4–10 – ISMS Development & Implementation

Develop policies, procedures, risk treatment plan, and implement security controls

03

Weeks 11–16 – Audit & Certification Readiness

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

Cost of Failure vs. the Benefit of ISO 27001

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

Streamlining ISO 27001 with the NHS DSP Toolkit

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.

Integrated Risk Management: ISO 27001 & ISO 14971

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.

Frequently Asked Questions (FAQs)

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.

Related Services

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Do you need Training?

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Jay Verma
15 days ago
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I found Patient Guard Ltd to be an exceptional partner. Their assessment was thorough, their guidance clear, and their support instrumental in helping us achieve our objectives. Steve and Ellie, in particular, were outstanding in steering us through the MHRA Class I medical device registration process.
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Munna P
68 days ago
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Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey. Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues. A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track. I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives. Thank you again to the entire Patient Guard team for being such reliable partners.
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Peter Reeve
94 days ago
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STEPPER design, manufacture & distribute eyewear across the globe. With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did! They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble. We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories. Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.
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Derek Timm
95 days ago
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For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd The staff are fantastıc nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted
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BMSCriticalCare
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Great service, very helpful and always willing to answer any questions we have,
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Thomson Software
803 days ago
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Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner. He was friendly, patient and willing to go the extra mile. Excellent service.
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Hannah Maddison
906 days ago
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Fantastic, knowledgeable team that are always there to help. My appointments have always been booked in very promptly and have always ended with all my queries resolved. I have found the team very flexible and their breadth of knowledge is second to none. Patient Guard are without doubt my go-to for all the regulatory aspects of my medical device role.
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Richard Crow
941 days ago
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Patientguard are an excellent source of Medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with Technical Files all the way through to using their ISO Templates to implement our ISO 13485 system.
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George Kitching
944 days ago
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David Small and PatientGuard have been extremely helpful and supportive in assisting us with producing and updating our Technical File and Appendices for MDR certification.
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Tracey Slater
944 days ago
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Patient Guard have been a great support service to Cormed, providing help and advice promptly when ever 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.
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