Capabilities and Resources
The responses and outputs generated by the Tyto virtual regulatory assistant are exclusively based on a set of predefined regulations, standards, and guidance documents listed below.
Regulatory Guide for Medical Device Compliance
The list includes the latest resources necessary for the establishment and upkeep of a quality management system compliant with medical device regulations. Additionally, it encompasses general resources essential for the effective development of medical devices.
Biocompatibility
ISO 10993-11 -2017- Biological evaluation of medical devices _ Part 11 Tests for systemic toxicity
Use of ISO 10993-1, Biological evaluation of medical devices - Part 1 - Evaluation and testing within a risk management process
ISO 10993-1 2025 Biological evaluation Medical Devices Part 1 Requirements and Principles within a risk management within a risk management process
ISO_10993-18_2020_Amd_1_2022 Biological evaluation of medical devices Part 18 Chemical characterization of MD materials within risk assessment process
ISO_10993-5_2009(en) Biological Evaluation of Medical Devices.
ISO_10993-10_2021(en) Biological Evaluation of Medical Devices
ISO_10993-23_2021(en)- Biological Evaluation of Medical Devices
ISO_10993-17_2023 Biological evaluation of medical devices Part 17 Toxicological risk assessment of MD constituents
ISO_10993-18_2020(en) Biological evaluation of medical devices
ISO_10993-17_2023_Amd_1_2025 Biological evaluation of medical devices
Clinical Evaluation
IMDRF MDCE WG N55 Clinical Evidence - Key Definitions and Concepts - 2019
MDCG-2020-5-Clinical Evaluation - Equivalence
MDCG 2020-13-Clincal Evaluation report template
IMDRF MDCE WGN56 - 2019-Clinical Evaluation
MDCG-2020-6-Regulation (EU) 2017 745 Clinical evidence needed for medical devices previously CE marked under Directives 93 42 EEC or 90 385 EEC
Clinical Investigations
IMDRF MDCE N57 - 2019 - Clinical Investigations
FDA - 2023 - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry
FDA - 2022 - Clinical Investigator Administrative Actions Disqualification
FDA - 2023 - Informed Consent Guidance for Institutional Review Boards Clinical Investigators and Sponsors
ISO 14155 - 2020 - Clinical investigation of medical devices for human subjects Good clinical practice
FDA 2023 Digital Health Technologies for Remote Data Acquisions in Clinical Investigations
Cybersecurity
ISO-IEC 27002-2022-Information security, cybersecurity and privacy protection _ Information security controls
IEC 81001-5-1 2021-Health software and health IT systems safety effectiveness and security- Security-Activities in the product life cycle
ISO-IEC 27005-2022-Information security, cybersecurity and privacy protection _ Guidance on managing information security risks
IMDRF CYBER WG N60-2020-Principles and Practices for Medical Device Cybersecurity
ISO-IEC 27004-2016-Information technology _ Security techniques _ Information security management systems _ Monitoring, measurement, analysis and evaluation
AAMI TIR57-2016_Principles for medical device security-Risk management
FDA-2016-Postmarket Management of Cybersecurity in Medical Devices
IMDRF CYBER WG N7-2023-Principles and Practices of Cybersecurity for Legacy Medical Devices Final (N70)_1
FDA-2005-Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
ISO-IEC 27001-2022-Information security, cybersecurity and privacy protection _ Information security management systems _Requirements
NTIA-2021-Framing Software Component Transparency - Establishing SBOM
MDCG 2019-16 Guidance on Cybersecurity for medical devices
FDA-2022-Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
ISO-IEC 27003-2017-Information technology _ Security techniques _ Information security management systems _ Guidance
IMDRF CYBER WG N73F-2023-Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity
ISO-IEC 27032-2012-Information technology _ Security techniques _ Guidelines for cybersecurity
FDA 2025 Cybersecurity in Medical Devices - Quality System Considerations and Content of Premarket Submissions
FDA 2023 Off-The-Shelf Software Use in Medical Devices
Electrical Safety and EMC
IEC-60601-1-AMENDMENT 2 - General requirements for basic safety and essential performance
IEC-60601-1-2-Electromagnetic disturbances _ Requirements and tests
IEC-60601-1-9 Requirements for environmentally conscious design
FDA - Electromagnetic Compatibility (EMC) of Medical Devices - 2022
IEC-60601-1-12-medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
IEC-60601-1-Medical electrical equipment _ General requirements for basic safety and essential performance
IEC-80601-2-26 _ Particular requirements for the basic safety and essential performance of electroencephalographs
IEC-80601-2-49-2018-Med ica l electrical equipment _Part 2-49 - Particular requirements for the basic safety and essential performance of multifunction patient monitors
IEC-60601-1-11-Medical electrical equipment - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC-60601-1-10 Requirements for the development of physiologic closed-loop controllers
IEC-60601-1-3 Radiation protection in diagnostic X-ray equipment
IEC 60601-2-7_1998 Medical electrical equipment - Part 2-7_ Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
IEC 61326-1_2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1_ General requirements
IEC 80601-2-77_2019 Medical electrical equipment - Part 2-77_ Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
IEC-80601-2-60-2019 Medical electrical equipment – Particular requirements for the basic safety and essential performance of dental equipment
FDA Special Control Guidances
General
IMDRF MDSAP WG N24 Medical Device Regulatory Audit Reports
ISO 10007 2017 Quality Management - Guidelines for configuration management
ISO 10004 2018 Quality Management - Customer Satisfaction - Guidelines for monitoring and measuring
IMDRF- RPS WG N19 FINAL-2016-Common Data Elements for Medical Device Identification
ISO 9001 2015-Quality Management System - Requirements
ISO 13485-2016-Practical-Guide
MDSAP-AU-P0002-Audit-Approach 2024-08-06
ISO 21500 2021 Project, programme and portfolio management - Context and concepts
ISO 10010 2022 Quality Management - Guidance to understand, evaluate and improve organizational quality culture
ISO-IEC-17025-2017 General requirements for the competence of testing and calibration laboratories
ISO 13485-2016-MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS REQUIREMENTS FOR REGULATORY PURPOSES
FDA 2017 Deciding When to Submit a 510k for a Change to an Existing Device
ISO 10009 2024 Quality-Management-Guidance-for-Quality-Tools and their application
ISO 9000 2015 Quality_management_systems
FDA-Part-11 -2003- Electronic Records Electronic Signatures-Scope-and-Application
ISO 10013 2021 Quality management systems. Guidance for documented information
FDA 1994 Design Control Guidance For Medical Device Manufacturers
ISO 19011 2018 Guidelines for auditing management system
Human Factors Engineering and Usability
IEC 62366-1-2015- Medical devices _ Part 1 Application of usability engineering to medical devices
FDA-2020-Content of Human Factors Information in Medical Device Marketing Submissions
Labeling
FDA 2017 Unique Device Identification - Direct Marking of Devices
IMDRF UDI WG N48-2019-Unique Device Identification system (UDI system) Application Guide
FDA 2021 Unique Device Identification System - Form and Content of the Unique Device Identifier (UDI)
FDA - General Device Labeling Requirements
IEC 80416-1_Basic principles for graphical symbols for use on equipment _Part 1 Creation of graphical symbols for registration-2008
ISO 780_Packaging - Distribution packaging - Graphical symbols for handling and storage packaging-2015
IMDRF - GRRP WG N52_2019-Principles of Labelling for Medical Devices and IVD Medical Devices-2019
ISO 20417-2021 Medical devices — Information to be supplied by the manufacturer
IEC-IEEE-82079-1-2019-Preparation-of-Information-for-Use-Instructions-for-Use-of-Products
Post Market Surveillance
MDCG-2020-8-Post-market clinical follow-up (PMCF) Evaluation Report Template
MDCG-2020-7-Post-market clinical follow-up (PMCF) Plan Template
IMDRF MDCE WG N65-2021 Post-Market Clinical Follow-Up Studies
IMDRF-AE-WG-N43 2020 IMDRF terminologies for categorized Adverse Event Reporting (AER) terms, terminology structure and codes
FDA-2022-Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
ISO_TR_20416_2020(en) Medical Devices-Post Market Surveillance for Manufacturers
Process Validation
IMDRF-PMD WG-N74_Personalized Medical Devices _ Production Verification and Validation-2023
FDA-2023-Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
FDA 2025 - Computer Software Assurance for Production and Quality System Software
Registration and Certification
FDA-2019-Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
FDA-2022-Refuse to Accept Policy for 510(k)s
FDA-2007-Bundling Multiple Devices or Multiple Indication in a Single Submission
IMDRF-GRRP WG-N47_Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices-2018
FDA-2017-Deciding When to Submit a 510(k) for a Software Change to an Existing Device
FDA-2018-Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
FDA-2020-510(k) Third Party Review Program
FDA-2014-Global Unique Device Identification Database (GUDID)
FDA-2023-Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
FDA-2017-Deciding When to Submit a 510(k) for a Change to an Existing Device
IMDRF-PMD WG-N58_Personalized Medical Devices _Regulatory Pathways-2023
IMDRF-RPS WG-N9-Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVDMAToC)-2019
FDA-2020-Multiple Function Device Products Policy and Consideration
IMDRF-UDI WG-N48_Unique Device Identification system (UDI system) Application Guide-2019
FDA-2023-Electronic Submission Template for Medical Device De Novo Requests
FDA-2017-Procedures for Meetings of the Medical Devices Advisory Committee
GHTF-SG1-N78_Principles of Conformity Assessment for Medical Devices-2012
IMDRF-RPS WG-N27-Assembly and Technical Guide for IMDRF Table of Contents Submissions-2019
FDA 2024 Global Unique Device Identification Database (GUDID)
FDA 2014 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
FDA 2023 Electronic Submission Template for Medical Device 510(k) Submissions
Regulation
21 CFR Part 820
2017-745_Medical Device Regulations (EU)-2017
Reprocessing
FDA-2015-Reprocessing Medical Devices in Health Care Settings Validation Methods and Labeling
ISO_17664-1_2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 1
ISO_17664-2_2021 Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices Part 2
ISO 21530 Materials Used for dental equipment surfaces-Determination of resistance to chemical disenfectants - 2004
AAMI TIR12_ 2010, Designining, testing and labeling reusable medical devices for reprocessing in health care facilities
Risk Management
AAMI TIR34971-2023 - Application of ISO 14971 to ML
AAMI TIR57-2016 - Principles for medical device security-Risk management
IMDRF SaMD WG N12F - 2014 - Software as a Medical Device - Possible Framework for Risk Categorization and Corresponding Considerations
AAMI ISO TIR24971-2020 - Guidance on the application of ISO 14971
ISO 14971-2019 - Application of risk management to medical devices
Software Development
MDCG 2023-4 Medical Device Software (MDSW) _ Hardware combinations
FDA 2002 General Principles of Software Validation
IEC 62304-2015-Medical device software _ Software life cycle processes
FDA 2019 Policy for Device Software Functions and Mobile Medical Applications
IMDRF SaMD WG (PD1) N23R-2015-Software as a Medical Device (SaMD) Application of Quality Management System
AAMI TIR45-2018-Guidance on the use of AGILE practices in the development of medical device software
IMDRF-SaMD WG N10-2013- Software as a Medical Device (SaMD) Key Definitions
FDA 2020 Multiple Function Device Products Guidance
FDA 2019 Off-the-Shelf Software Use in Medical Devices
FDA Proposed Regulatory Framework for Modifications to Artificial Intelligence Machine Learning (AI ML)-Based Software
IMDRF AIMD WG N67 - 2022 - Machine Learning-enabled Medical Devices Key Terms and Definitions
FDA 2024 Guidance-Predetermined-Change-Control-AIML
FDA 2023 Premarket Software Functions Guidance
IEC 82304-2016-Health software - General requirements for product safety
FDA 2023 Marketing Submission Recommendations for a Predetermined Change Control Plan for AI and ML-Enabled Device Software Functions
IEC-TR-80002 2009 Guidance on the application of ISO 14971 to medical device software
IEC-TR-80002-3- Medical device software Part 3 Process reference model of medical device software life cycle processes (IEC 62304) 2014