EU Medical Devices Regulation
The European Union Medical Device Regulation (EU MDR) is a comprehensive set of rules that govern the design, manufacture, and distribution of medical devices within the EU.
The regulation emphasizes a lifecycle approach to safety, promoting constant monitoring and periodic updates to ensure the ongoing safety and efficacy of medical devices. Importantly for the AI field, EU MDR is applicable to medical devices that are AI-powered, requiring them to meet specific criteria related to safety, performance, and data governance.
This includes conducting clinical evaluations, post-market surveillance, and ensuring that the devices have appropriate risk management and quality management systems in place.
Deviceology specialises in aiding businesses to align their AI-powered medical devices with the stringent requirements of the EU MDR.
Our team of experts offer an end-to-end service that encompasses initial assessments, gap analysis, and actionable roadmaps for compliance.
We guide you through the nuances of clinical evaluations, risk management, and data governance specific to AI technologies. We offer assistance in setting up robust quality management systems and protocols for post-market surveillance, ensuring ongoing compliance and adaptability to regulatory changes.
ISO 13485 Quality Management System
ISO 13485 is the international standard that outlines the requirements for a quality management system specifically for organisations involved in the medical device industry, including manufacturers and service providers.
It emphasises various areas crucial for medical devices, such as risk management, quality assurance, and post-market surveillance/
Deviceology offers a comprehensive suite of services designed to help organisations implement a compliant QMS under ISO 13485, get it certified, and maintain it over the lifetime of the certification.
Our team guides you through the intricate requirements of the standard, offering assistance in documentation, training, and internal auditing.
We help you establish risk management processes, quality assurance protocols, and post-market surveillance mechanisms tailored to the unique challenges posed by AI technologies. Post-certification, we offer ongoing support to manage you system and operate effective Post Market Surveillance, as well performing periodic audits to ensure that your QMS stays up-to-date with any amendments to ISO 13485 or related regulations, allowing you to focus on innovation while we ensure that your product meets the highest quality and safety standards.
ISO 14971 Risk Management
ISO 14971 is the international standard that defines the framework for risk management processes specific to medical devices, including those powered by AI technologies. Recognised globally, this standard is pivotal for organisations in the medical device sector, from manufacturers to developers.
ISO 14971 offers a systematic approach to identify potential hazards, assess associated risks, implement controls, and monitor their ongoing effectiveness throughout the medical device’s lifecycle. Adherence to ISO 14971 not only signifies a device’s safety and efficacy but also complements other standards like ISO 13485, especially in areas of risk assessment and mitigation.
Compliance with ISO 14971 is increasingly viewed as an essential component in meeting international regulatory requirements, including those set by the European Union Medical Device Regulation (EU MDR). Emphasising comprehensive risk management strategies, this standard is instrumental for gaining market access in the EU, the United States, and beyond.
At Deviceology, we provide an extensive range of services geared towards helping organisations seamlessly integrate ISO 14971’s risk management processes. Our team of experts assists in hazard identification, risk evaluation, control implementation, and post-production feedback.
With Deviceology by your side, you can pioneer in the medical device sector, confident in the knowledge that your products align with the most stringent safety and quality benchmarks.
UK Medical Devices Regulation
The UK Medical Device Regulation (UK MDR) governs the design, manufacturing, and distribution of medical devices within the United Kingdom. Similar to its EU counterpart, the UK MDR also adopts a lifecycle approach to medical device safety, encompassing aspects from design to post-market surveillance.
For medical devices manufacturers, this means complying with stringent regulations focused on clinical evaluations, data governance, safety assessments, and quality management. The regulation aims to ensure that medical devices, including those leveraging AI technologies, meet the necessary standards to ensure patient safety and product efficacy.
Deviceology is ideally positioned to help businesses navigate the complexities of UK MDR compliance for medical devices.
Our team of experts offer a comprehensive suite of services, starting from initial compliance assessments to roadmap development for aligning your product features and operational protocols with the UK MDR requirements. We assist in the design and implementation of rigorous clinical evaluations and safety assessments in preparation for you Notified Body certification audits.
Additionally, we help establish and maintain robust quality management systems to ensure ongoing compliance and adaptability to potential changes in regulations. With our specialised services, you can be confident that your medical devices not only fulfill the regulatory requisites of the UK MDR but also offer a competitive edge through guaranteed safety and quality.
United States Food and Drug Administration
The United States Food and Drug Administration (FDA) has specific regulations governing the development, production, and marketing of medical devices.
Depending on the risk classification and the similarity to existing devices, manufacturers may choose different pathways for FDA approval, such as the 510(k) premarket notification process for devices that are similar to those already on the market, or the De Novo pathway for low to moderate risk devices that are novel and unlike any existing classified devices..
Deviceology provides a range of services to help companies with medical devices navigate the complex FDA regulatory landscape. Whether your device is better suited for the 510(k) pathway or the De Novo process, our team of experts can guide you through each step, from pre-submission consultations to post-market surveillance.
We help you compile the necessary documentation and evidence, focusing on areas like clinical validation, risk management, and data governance, tailored to the unique attributes of AI technologies. Our services also include mock FDA audits to prepare you for the real thing and a comprehensive quality management system that aligns with FDA requirements.
Our objective is to simplify the FDA compliance process for you, ensuring that your medical devices meet the most stringent safety and efficacy criteria, thereby facilitating a smoother, more predictable path to market.
Other Regulations, Standards and Frameworks
There exists a myriad of regulations, international standards, and frameworks that necessitate specialised support for the implementation of appropriate controls and, where applicable, the demonstration of compliance. Should you find that the specific guidelines you require assistance with are not listed above, please do not hesitate to reach out to us. We are sure we can provide you with the expert guidance you need.
