ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) for medical device manufacturers and suppliers. Developed by the International Organization for Standardization (ISO), ISO 13485 is specifically tailored to ensure compliance with regulatory requirements in the medical device industry.
The standard outlines requirements for the design, development, production, installation, and servicing of medical devices. It focuses on ensuring that medical devices consistently meet customer and regulatory requirements, including safety, effectiveness, and quality.
Key elements of ISO 13485 include:
ISO 13485 certification involves a third-party audit by a certification body to assess whether an organization’s quality management system complies with the requirements of the standard. Certification demonstrates that the organization has implemented robust quality management practices and is committed to producing safe and effective medical devices that meet regulatory requirements. It can enhance credibility, facilitate market access, and improve customer confidence in the organization’s products and services.
Regulatory Compliance:
Ensures alignment with regulatory standards, a critical factor for gaining market access and maintaining competitiveness in the medical device industry.
Enhanced Product Quality:
Promotes robust processes and controls, improving product quality, reducing defects or recalls, and enhancing customer satisfaction.
Risk Management:
Places a strong emphasis on risk management throughout product development, manufacturing, and post-market activities, ensuring patient and user safety.
Global Market Access:
Internationally recognized and accepted, facilitating market access to various regions worldwide and enabling entry into new markets.
Process Efficiency and Effectiveness:
Encourages the implementation of efficient and effective processes, standardizing procedures, documentation, and controls to streamline operations and optimize resource utilization.
Continuous Improvement:
Fosters a culture of continuous improvement, enabling organizations to monitor performance, collect data, analyse metrics, and adapt to evolving customer needs.
ISO 13485 is vital for your business as it guarantees regulatory compliance, elevates product quality, mitigates risks, facilitates global market access, improves process efficiency, and instils a culture of continuous improvement. This standard provides a framework for excellence in the medical device industry, demonstrating your commitment to delivering safe and effective products to customers worldwide.
In order to get a fixed price proposal please complete the following Cyber Security Consultancy Next Steps and select Cyber Essentials Fixed Price Proposal
Unsupported operating systems will not meet Cyber Essentials or Cyber Essential Plus certification and organisations often feel pressured to upgrade their systems, which could mean significantly increased costs and having to re-engineer applications to run on new platforms.
If you are developing, or have developed your own applications, you need to be able to deploy safely and securely and meet the requirements of Cyber Essentials and Cyber Essentials Plus, this is where our Legacy Application Security solution from Droplet will enable you to meet the requirements without the additional burden and overhead of re-platforming your legacy applications and operating systems.
Most companies rely on digital offerings and services as part of their day to day business, but where there is information technology there is an element of information security risk. These organisations will at some time come under some form of threat from cyber criminals. This self-assessment and audited Cyber Essentials option will give you protection against a wide variety of the most common cyber-attacks.
Your Cyber Essentials certification will:
In April 2023, the NCSC and its Cyber Essentials delivery partner IASME will update the technical requirements for Cyber Essentials. This update is part of a regular review of the scheme’s technical controls, ensuring that it continues to help UK organisations guard against the most common cyber threats.
After a major update last year – the biggest update to the scheme since it was first set up in 2014 – the 2023 update will be lighter touch, providing a number of clarifications, alongside some important new guidance. This includes:
User devices.
With the exception of network devices (such as firewalls and routers), all user devices declared within the scope of the certification only require the make and operating system to be listed. We have removed the requirement for the applicant to list the model of the device. This change will be reflected in the self-assessment question set, rather than the requirements document.
Clarification on firmware.
All firmware is currently included in the definition of ‘software’, and so must be kept up to date and supported. Following feedback that this information can be difficult to find, we are changing this to include just router and firewall firmware.
Third party devices.
More information and a new table that clarify how third-party devices, such as contractor or student devices, should be treated in your application.
Device unlocking.
They have made a change there to mitigate some issues around default settings in devices being unconfigurable (such as the number of unsuccessful login attempts before the device is locked). Where that is the case, it’s now acceptable for applicants to use those default settings.
Malware protection.
Anti-malware software will no longer need to be signature based and they have clarified which mechanism is suitable for different types of devices. Sandboxing is removed as an option.
Zero Trust
New guidance on zero trust architecture for achieving CE and a note on the importance of asset management.
Style and language.
Several language and format changes have been made to make the document easier to read.
Structure updated.
The technical controls have been reordered to align with the updated self-assessment question set.
Cyber Essentials and Cyber Essentials Plus Testing.
The CE+ Illustrative Test Specification document has been updated to align with the requirements changes. The biggest change there is a refreshed set of Malware Protection tests, to simplify the process for both applicants and assessors.
All these changes are based on feedback from assessors and applicants, and have been made in consultation with technical experts from the NCSC. As well as the updated requirements and new question set, IASME are also providing more guidance documents to help applicants during the certification process. This includes articles to help applicants understand the questions, as well as access to a dedicated knowledge base.
This latest update (version 3.1) will take effect from 24 April 2023. This means all applications started on or after this date will use the new requirements and question set.
This section highlights testimonials and evaluations from our clients, showcasing how we continuously strive to enhance our services. Your feedback helps us grow and ensures we meet your needs effectively
AEC provided a superb Online ISO9001 Auditor class. One of the most important aspects was their ability to conduct the 4-day class in a live web-based format! In these times of tight budgets this saved our company the associated travel expenses. I highly recommend AEC!
We really enjoyed the 9001 course that we took through AEC and were able to take the knowledge that we gained through that course to allow us to successfully have our ISO certification renewed for another three years. Thank you for your time and assistance.
