For nearly 10 years, Knowllence has been an expert member of the AFNOR/S95b Medical Devices Standardization Committee, focusing on quality management and general aspects of medical devices.
Our active participation in the S95b committee allows us to engage within a dynamic network and contribute directly to the development or clarification of new standards.
As a result, our Medical Device Software is always closely aligned with standardization principles, helping our clients work with confidence and prepare for compliance with MDR, ISO, and FDA requirements.
Why Knowllence Get Involved in Medical Device Standardization?
Our Medical Device Suite software is used by medical device manufacturers for product design, post-market monitoring, and preparation of regulatory submission documents. We are therefore fully committed to supporting our clients in achieving compliance, particularly with ISO 14971:2019, IEC 62304, and in implementing a Quality Management System (QMS) according to ISO 13485:2016 or 21 CFR Part 820.
It is in our team’s DNA to master standards and best practices: from the X50-151 standard at our founding in 1990 on functional specifications, to the most recent automotive FMEA reference (AIAG-VDA) in 2019.
Our ambition is to provide a fully digital system for managing all risk studies related to medical devices (and their variants) within a coherent and interconnected database. Understanding the interplay between different regulatory requirements is complex and regularly reveals gray areas or gaps that require careful attention.
Our active participation in the S95b standardization committee allows us to engage within a dynamic network and contribute directly to the development or clarification of new standards. It also ensures we benefit from methodological, strategic, and tactical support, promoting French interests on the global stage.
Why are specific standards necessary for Medical Devices?
(These elements are extracted from the document x001AA “Bilan et Perspectives 2019-2020 – CN Quality Management of Medical Devices – S95B AFNOR”)
The medical device sector is highly diverse, with products intended for use by highly trained professionals, non-specialists, and patients alike. One common expectation is that all users rely on products to perform as intended.
Moreover, regulatory authorities must ensure that safe, effective, and high-quality products serve public health. Consequently, quality management for medical devices spans a wide range of activities: product design (including risk management and usability), manufacturing and distribution, installation, documentation and training, as well as post-market surveillance. The sector is structurally diverse, with multiple stakeholders including patients, individual users, manufacturers and distributors, healthcare providers (hospitals, clinics), and health organizations.
Medical device manufacturers range from multinational corporations to small and medium-sized enterprises and even startups. The sector is strongly influenced by regulatory authorities. Conformity assessment bodies, often independent organizations, assist in determining whether medical devices comply with applicable regulatory requirements.
Risk management for medical devices follows a lifecycle approach, with collected data fed back into the quality management system.
The objectives of ISO/TC 210 “Quality Management and General Aspects for Medical Devices” and CEN-CLC/JTC 3 “Quality Management and General Aspects for Medical Devices” are:
- Protect the health and safety of users and patients – Safety and performance requirements for different types of medical devices are strengthened by identifying common quality principles in general standards.
- Eliminate barriers to trade – European cooperation within CEN-CENELEC/JTC 3, and internationally within ISO/TC 210 and IEC/SC 62A, helps remove trade barriers.
- Promote global regulatory harmonization – Facilitate understanding of the role and application of quality management and encourage adoption of the quality management practices required by regulators and manufacturers. Harmonized standards play a key role in demonstrating compliance with essential requirements. Many European standards are harmonized, simplifying the interpretation of quality and risk management requirements under the regulatory framework.
- Achieve consensus and compatibility with other ISO and IEC standards – Share quality and risk management principles with other technical committees across all areas of medical technology.
For example, considering medical software as a medical device requires close interaction between experts developing medical device risk management standards (EN ISO 14971 – Application of Risk Management to Medical Devices) and those developing health software risk management standards (EN ISO 27799 – Health Informatics – Security Management in Healthcare Using EN ISO/IEC 27002).
For more information (in French)
Medical Device Software and Regulatory Standardization
The different modules of Medical Device Software each enable the implementation of a standard or framework within a coherent and interconnected database:
- RM 14971 – for risk management according to ISO 14971:2019, usability (62366), and software risk analysis (62304)
- Need – for external functional analysis (European standards EN 1325-1, French standards EN 16271 (formerly NF X50-151)), APTE® method, etc.
- Structure – for technical functional analysis (functional block diagram, SADT, TAF)
- FMEA – for Design FMEA, Process FMEA, and Control Plans
- FTA – for fault tree analysis
The reports and indicators provided, in addition to the structured studies and generic templates, help support compliance of your Quality Management System in accordance with ISO 13485:2016.