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ISO 27001 ISMS and Medical Device Cybersecurity Consulting

ISO 27001 provides an international methodology for the implementation, management, and maintenance of information security within a company. 

Becoming ISO 27001 certified demonstrates conformity of your Information Security Management System (ISMS) with the documented standards and provides your customers with assurance regarding the security of your system.

Why Consider ISO 27001

Conformity to ISO 27001 demonstrates that you take cybersecurity seriously. Any organization that holds sensitive information is a candidate for ISO 27001 certification. In particular, companies in the healthcare, finance, public, and IT sectors can benefit greatly from a certified ISMS.

ISO 27001 for Med Tech

From hospital equipment that’s connected to wi-fi to implantables that are Bluetooth-enabled, many of today’s devices are designed to incorporate software connected to information networks into their primary functions. In addition to relying on connectivity to operate, many of these devices collect and store large amounts of confidential patient and diagnostic data.

This kind of functionality brings new sources of risk that extend beyond the traditional risks of device failure. With cybersecurity events on the rise across the globe, medical device manufacturers must take seriously any risks from forces intentionally trying to break into devices. Patients’ medical data is often the highest-risk data they have. Identity theft can be disputed, credit scores can be rebuilt, but health information cannot be changed. As a result, patients and regulators are demanding cybersecurity controls and protections more than ever.

While an ISO 27001 certification will not prevent cybersecurity events from happening, designing your program to the standard will reduce the overall risk by ensuring that your program is comprehensively addressing all aspects of cybersecurity.

How Can Oriel STAT A MATRIX Help

In order to earn an ISO 27001 certification, an organization is required to maintain an ISMS that covers all aspects of the standard. Oriel STAT A MATRIX provides support to:

  • Develop an ISMS compliant to ISO 27001
  • Strengthen an existing ISO 27001 ISMS
  • Sustain ISMS compliance over time, including support for ISO 27001 internal audits
  • Train your own staff on ISO 27001 and related topics like Cybersecurity.

Why Choose Oriel STAT A MATRIX

Since 1968, organizations have relied on Oriel STAT A MATRIX for ISO related training and consulting. We have trained more than 130,000 auditors and helped thousands of organizations attain certification to ISO standards.

Our team of ISO 27001 consultants has:

  • In depth, real-world knowledge of ISMS Standard
  • Extensive experience implementing and maintaining information security management systems
  • Experience auditing 27001 conformity for notified bodies
  • Sat on ISO technical committees on risk management, and government regulatory committees regarding cybersecurity

Develop an ISMS compliant to ISO 27001

Oriel STAT A MATRIX has successfully assisted thousands of organizations in attaining certification to ISO 9000 and related ISO standards like ISO 27001 using our 14-step process.

The Program:

  • Focuses on increasing organizational effectiveness and efficiency.
  • Yields a framework that ensures process consistency and optimal results going forward.
  • Transfers knowledge and skills through coaching, mentoring, and training, thus ensuring that your organization remains successful after we leave.

Phase I (Steps 1 – 3)

If you already have a limited ISMS in place, we will first assess your current level of ISMS compliance. This process will uncover opportunities for improvement and yield the information needed to make an informed assessment of the amount of time and resources required to comply with ISMS. From here we will provide a detailed roadmap that will be used to prepare for your initial ISO 27001 certification audit.

An optional Risk Assessment to ISO/IEC 27005 can be conducted during Phase I.  The cornerstone of the ISMS is an information security risk assessment. For clients have not completed one, this service can be integrated into the ISMS development process.

Phase 1 provides an understanding of:

  • Your current level of compliance
  • Where in the organization there are opportunities for improvement
  • The required path to move forward towards certification
  • The amount of time and resources required to move forward with certification

Phase II (Steps 4 – 14)

During the second phase of the program we will develop an action plan for you that will take you all the way to the point where you will be ready for your ISO 27001 certification audit.

A key step in this Phase is Policy Development. During this step we provide a customized policy stack that can be implemented to achieve ISO 27001 certification. 

Typical Policies include:

  • Information Security Policy (For Employees)
  • ISMS Policy/Charter (Program establishment)
  • ISMS scoping document
  • ISMS/Risk Committee Charter
  • ISMS Risk Assessment Plan/Procedure
  • Mobile Device/Telework Policy
  • Human Resources Security Policy
  • Asset Management & Disposal Policy
  • Acceptable Use Agreement
  • Information Classification
  • Access Control Policy
  • Cryptography Policy
  • Physical Security Policy
  • IT Security Policy
  • Third Party & Supplier Security Policy
  • Incident Response Plan/Procedure
  • Business Continuity / Disaster Recovery Plan

ISO 27001 Training 

  • ISO 27001 Executive Management Training: What does ISO 27001 certification entail?
  • ISO 27001 Overview Training: Understand New and Revised Process so that your organization can maintain compliance and ensuring successful surveillance outcomes
  • ISO 27001 Audit Best Practices
Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.
Course Name Public Private
Medical Device Cybersecurity Risk Management Standards & Regulations Training Course

If your company makes connected devices, you know cybersecurity is paramount. Click to learn more.

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