- Structure requirements and clarify specifications
- secure the design
- efficiently prepare for audits — whether under MDR, ISO 13485, ISO 14971, IEC 62366, IEC 62304, as well as the FDA framework and 21 CFR Part 820.
Why a Functional Analysis module in Medical Device Software?
Functional analysis with Medical Device Software enables multidisciplinary teams (regulatory affairs, design office, quality, risk management, and engineering) to ask the right questions from the very beginning in order to properly structure a medical device project. By relying on a clear, complete, and solution-independent functional expression, it ensures a shared understanding of the need before any technical decisions are made.
Structuring the requirement in a normative way
The module is based on robust and widely recognized methodological foundations such as:
- APTE Method,
- EN 1325-1,
- NF X50-151,
which enable a faithful, exhaustive, and objective expression of the expected functions of the medical device. This approach naturally structures the Functional Specification Document (FSD), but also feeds into the quality control processes defined in 21 CFR Part 820 (QSR), in particular:
- 820.30 Design Controls,
- 820.100 Corrective and Preventive Actions (CAPA),
- 820.70 Production and Process Controls.
Indeed, functional analysis directly supports FDA-recommended steps regarding the definition of Design Inputs, identification of critical requirements, and verification of compliance.
A tool aligned with international regulatory requirements (MDR, ISO, FDA)
1. Compliance with European Regulation (EU) 2017/745 — MDR
The functional analysis module of Knowllence helps meet the essential requirements of the MDR, in particular:
- the justification of the intended use and clinical need,
- the precise definition of safety and performance requirements,
- the generation of essential documentation for the Technical Documentation file.
2. Alignment with FDA requirements: 21 CFR Part 820 — QSR
The FDA requires a rigorous and structured design process. The functional analysis addresses in particular the following elements:
- Definition and validation of Design Inputs (820.30(c)),
- Development and justification of Design Outputs (820.30(d)),
- Identification of risks associated with functions and characteristics (as an integral part of Design Controls),
- Support for verification/validation activities and Design Change management (820.30(i)).
Thus, the integrated functional analysis module of Knowllence directly supports an FDA-compliant approach for devices intended for the U.S. market.
Integration of GxP principles: consistency, traceability, and data integrity
The Knowllence web-based functional analysis software also supports cross-functional best practices in the industry, including:
- GDocP / GDP (Good Documentation Practices): by ensuring structured and unambiguous traceability,
- GMP / cGMP (Good Manufacturing Practices): by providing a solid functional foundation for process validation and control,
- GLP (Good Laboratory Practices) when design activities interface with pre-clinical verification phases,
- GCP (Good Clinical Practices) through its impact on intended use characteristics and clinical suitability.
The GxP principles are based on data integrity (ALCOA+), consistency, and the justification of design decisions — all of which are made explicit through structured functional analysis within Medical Device Software.
A reliable foundation for ISO 14971 and FDA risk analyses
Functional analysis is the starting point of the risk-based approach required by:
- ISO 14971 (risk analysis, control, and documentation),
- FDA Design Controls,
- MDR requirements related to benefit–risk balance.
Medical Device Software ensures continuity between:
- functions,
- requirements,
- risks,
- tests,
- regulatory documentation.
As a result, every technical evolution (Design Change) is automatically traced, and its impacts are assessed across the entire lifecycle.
Complete traceability and control of Design Changes
Under both the MDR and 21 CFR Part 820, traceability is a key pillar. The Medical Device Software web solution ensures:
- bidirectional traceability,
- impact visualization,
- automatic linking between requirements, design, risks, tests, and product versions.
This directly supports compliance with:
- UDI / traceability requirements (MDR),
- Document Control (820.40 FDA),
- Design History File (DHF),
- Device Master Record (DMR),
- Device History Record (DHR).
Robust and transparent management of requirement evolution
The evolution of a medical device project requires regularly revisiting requirements, functions, and expected performance. The functional analysis software from Medical Device Software ensures full traceability of every functional data element, including:
- usage phases,
- functions,
- performance criteria,
- constraints, interactions, and service levels.
Thanks to the integrated audit trail, users can view:
- all modification dates,
- the author of each change,
- the modified content,
- the successive versions of each item,
- the impacts on related modules (risks, usage, FMEA, etc.).
Teams can therefore easily:
- filter information modified since the last project review,
- reconstruct the full history of a performance or requirement,
- justify design decisions more easily during audits (MDR, ISO 13485, 21 CFR Part 820).
An integrated platform for design, risk management, and compliance
The Functional Analysis module works in synergy with the other modules of Medical Device Software:
- ISO 14971 risk management (RM 14971),
- FMEA,
- validation and monitoring plans,
- fault tree analysis and reliability engineering,
- traceability matrix.
This consistent architecture — built on a single unified database — eliminates duplicates, prevents inconsistencies, enhances audit readiness, and accelerates updates.
Powerful graphical tools for optimized team collaboration
The visual environment of Medical Device Software enhances collaboration during workshop sessions, a key format for aligning regulatory affairs, engineering, design, risk management, and quality teams. The interface includes in particular:
- the “octopus diagram” (system interaction with its environment),
- the completeness matrix,
- cross classification analysis,
- the interactive functional tree.
When used for video-projected workshops, these tools enable:
- smooth and dynamic facilitation of working sessions,
- real-time updates of functions and their characteristics,
- improved collective ownership of decisions,
- significant time savings during meetings,
- faster validation cycles through immediate sharing of documents and actions between sessions.
Increased responsiveness in drafting and evolving medical device specifications
The collaborative and graphical features of the Knowllence functional analysis software enable teams to:
- define requirements more quickly,
- adjust functions in real time based on group discussions,
- document decisions immediately,
- share characterization tables and action plans,
- reduce back-and-forth in the drafting of the Functional Specification Document (FSD) or Design Inputs.
This efficiency strengthens the ability of engineering and regulatory teams to respond quickly to new constraints, clinical feedback, regulatory changes, or design modifications.
Medical Device Software: the collaborative software you need!
Thanks to its Functional Analysis module, Medical Device Software provides manufacturers with a complete solution aligned with international best practices (EU MDR, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, GxP). It enables you to:
- structure requirements and build a robust Functional Specification Document (FSD),
- control requirements and ensure full traceability,
- initiate a consistent and comprehensive risk analysis,
- confidently respond to European and FDA audits,
- efficiently manage product evolution and design changes.
An essential tool to design, document, and certify safe, high-performance, and compliant medical devices.