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_10993-5_2009(en) Biological Evaluation of Medical Devices.
ISO_10993-10_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_Amd_1_2022 Biological evaluation of medical devices Part 18 Chemical characterization of MD materials within risk assessment process
ISO_10993-23_2021(en)- Biological Evaluation of Medical Devices
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 WGN56 - 2019-Clinical Evaluation
MDCG 2020-13-Clincal Evaluation report template
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
IMDRF MDCE WG N55 Clinical Evidence - Key Definitions and Concepts - 2019
MDCG-2020-5-Clinical Evaluation - Equivalence
Clinical Investigations
ISO 14155 - 2020 - Clinical investigation of medical devices for human subjects Good clinical practice
FDA - 2022 - Clinical Investigator Administrative Actions Disqualification
IMDRF MDCE N57 - 2019 - Clinical Investigations
FDA - 2023 - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry
FDA - 2023 - Informed Consent Guidance for Institutional Review Boards Clinical Investigators and Sponsors
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-80601-2-60-2019 Medical electrical equipment – Particular requirements for the basic safety and essential performance of dental equipment
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
FDA Special Control Guidances
General
ISO 13485-2016-Practical-Guide
IMDRF MDSAP WG N24 Medical Device Regulatory Audit Reports
ISO 10007 2017 Quality Management - Guidelines for configuration management
MDSAP-AU-P0002-Audit-Approach 2024-08-06
IMDRF- RPS WG N19 FINAL-2016-Common Data Elements for Medical Device Identification
ISO 9001 2015-Quality Management System - Requirements
ISO 10004 2018 Quality Management - Customer Satisfaction - Guidelines for monitoring and measuring
ISO 13485-2016-MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS REQUIREMENTS FOR REGULATORY PURPOSES
ISO 9000 2015 Quality_management_systems
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
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 21500 2021 Project, programme and portfolio management - Context and concepts
FDA 1994 Design Control Guidance For Medical Device Manufacturers
ISO 19011 2018 Guidelines for auditing management system
FDA-Part-11 -2003- Electronic Records Electronic Signatures-Scope-and-Application
ISO 10013 2021 Quality management systems. Guidance for documented information
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
IMDRF MDCE WG N65-2021 Post-Market Clinical Follow-Up Studies
MDCG-2020-8-Post-market clinical follow-up (PMCF) Evaluation Report Template
MDCG-2020-7-Post-market clinical follow-up (PMCF) Plan Template
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