Back to Frameworks
IEC 62304:2015 Medical Device Software Lifecycle Processes
International (IEC); harmonised as EN 62304 under the EU MDR; FDA recognised consensus standard; adopted as ANSI/AAMI/IEC 62304 and nationally
vEdition 1.1 (IEC 62304:2006 + A1:2015)
6 domains
99 controls
The IEC standard for medical device software life cycle processes, built from the complete Edition 1.1 text (2006 with Amendment 1:2015): 99 requirement leaves across development, maintenance, risk management, configuration management and problem resolution, each marked with the software safety classes A, B and C it applies to.
Verified
IEC 62304:2015 Medical Device Software Lifecycle Processes is a compliance framework from International (IEC); harmonised as EN 62304 under the EU MDR; FDA recognised consensus standard; adopted as ANSI/AAMI/IEC 62304 and nationally with 6 domains and 99 controls that map to 194 other frameworks. The largest domains are Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes (54 controls), Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes (13 controls), Clause 4: general requirements (quality system, risk management, safety classification, legacy software) – IEC 62304:2015 Medical Device Software Lifecycle Processes (8 controls). Every control below carries what it requires and what an assessor expects to see.
Maintained by Gerard BlokdykControl text last updated
Framework summaries on this platform are interpretations grounded in the published source, for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (6)
Clause 4: general requirements (quality system, risk management, safety classification, legacy software) – IEC 62304:2015 Medical Device Software Lifecycle Processes
8 controls
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes
54 controls
Clause 6: software maintenance process – IEC 62304:2015 Medical Device Software Lifecycle Processes
8 controls
| Code | Title |
|---|---|
| iec-62304-2015-medical-device-software-lifecycle-processes::6.1 | 6.1 Establish software maintenance plan |
| iec-62304-2015-medical-device-software-lifecycle-processes::6.2.1 | 6.2.1 Document and evaluate feedback |
| iec-62304-2015-medical-device-software-lifecycle-processes::6.2.2 | 6.2.2 Use software problem resolution process |
| iec-62304-2015-medical-device-software-lifecycle-processes::6.2.3 | 6.2.3 Analyse change requests |
| iec-62304-2015-medical-device-software-lifecycle-processes::6.2.4 | 6.2.4 Change request approval |
| iec-62304-2015-medical-device-software-lifecycle-processes::6.2.5 | 6.2.5 Communicate to users and regulators |
| iec-62304-2015-medical-device-software-lifecycle-processes::6.3.1 | 6.3.1 Use established process to implement modification |
| iec-62304-2015-medical-device-software-lifecycle-processes::6.3.2 | 6.3.2 Re-release modified software system |
Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes
13 controls
| Code | Title |
|---|---|
| iec-62304-2015-medical-device-software-lifecycle-processes::7.1.1 | 7.1.1 Identify software items that could contribute to a hazardous situation |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.1.2 | 7.1.2 Identify potential causes of contribution to a hazardous situation |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.1.3 | 7.1.3 Evaluate published SOUP anomaly lists |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.1.4 | 7.1.4 Document potential causes |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.1.5 | 7.1.5 Document sequences of events |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.2.1 | 7.2.1 Define risk control measures |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.2.2 | 7.2.2 Risk control measures implemented in software |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.3.1 | 7.3.1 Verify risk control measures |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.3.2 | 7.3.2 Document any new sequences of events |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.3.3 | 7.3.3 Document traceability |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.4.1 | 7.4.1 Analyse changes to medical device software with respect to safety |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.4.2 | 7.4.2 Analyse impact of software changes on existing risk control measures |
| iec-62304-2015-medical-device-software-lifecycle-processes::7.4.3 | 7.4.3 Perform risk management activities based on analyses |
Clause 8: software configuration management process – IEC 62304:2015 Medical Device Software Lifecycle Processes
8 controls
Clause 9: software problem resolution process – IEC 62304:2015 Medical Device Software Lifecycle Processes
8 controls
| Code | Title |
|---|---|
| iec-62304-2015-medical-device-software-lifecycle-processes::9.1 | 9.1 Prepare problem reports |
| iec-62304-2015-medical-device-software-lifecycle-processes::9.2 | 9.2 Investigate the problem |
| iec-62304-2015-medical-device-software-lifecycle-processes::9.3 | 9.3 Advise relevant parties |
| iec-62304-2015-medical-device-software-lifecycle-processes::9.4 | 9.4 Use change control process |
| iec-62304-2015-medical-device-software-lifecycle-processes::9.5 | 9.5 Maintain records |
| iec-62304-2015-medical-device-software-lifecycle-processes::9.6 | 9.6 Analyse problems for trends |
| iec-62304-2015-medical-device-software-lifecycle-processes::9.7 | 9.7 Verify software problem resolution |
| iec-62304-2015-medical-device-software-lifecycle-processes::9.8 | 9.8 Test documentation contents |
Your Compliance Coverage
If you comply with IEC 62304:2015 Medical Device Software Lifecycle Processes, you already cover:
EN 50716:2023 - Railway Applications - Requirements for Software Development
31%
41 controls mapped
Compare →GAMP 5 - Good Automated Manufacturing Practice
10%
13 controls mapped
Compare →ICH Q10 - Pharmaceutical Quality System
7%
9 controls mapped
Compare →+ 191 more: NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security (6%), MTCS (Singapore) (6%)
See all 194 mapped frameworks ↓Maps to 194 other frameworks
132 total controls
EN 50716:2023 - Railway Applications - Requirements for Software Development
41 source controls mapped|21 target controls covered
31%
GAMP 5 - Good Automated Manufacturing Practice
13 source controls mapped|19 target controls covered
10%
ICH Q10 - Pharmaceutical Quality System
9 source controls mapped|3 target controls covered
7%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
8 source controls mapped|4 target controls covered
6%
MTCS (Singapore)
8 source controls mapped|3 target controls covered
6%
Annex 11 to EU GMP - Computerised Systems
8 source controls mapped|4 target controls covered
6%
SSAE 18 - Attestation Standards (SOC Reporting)
8 source controls mapped|5 target controls covered
6%
ISO 26262:2018 - Functional Safety for Road Vehicles
8 source controls mapped|4 target controls covered
6%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
7 source controls mapped|6 target controls covered
5%
NIST SP 800-146
7 source controls mapped|2 target controls covered
5%
NIST SP 800-145
7 source controls mapped|2 target controls covered
5%
NIST SP 800-144
7 source controls mapped|2 target controls covered
5%
ISMAP (Japan)
7 source controls mapped|3 target controls covered
5%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.4)
7 source controls mapped|2 target controls covered
5%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
7 source controls mapped|7 target controls covered
5%
South Korea ISMS-P
7 source controls mapped|4 target controls covered
5%
ISO 20400:2017 - Sustainable Procurement
7 source controls mapped|4 target controls covered
5%
ISO/IEC 27003:2017
7 source controls mapped|4 target controls covered
5%
NIST SP 800-190
7 source controls mapped|4 target controls covered
5%
OSFI B-13
6 source controls mapped|3 target controls covered
5%
TISAX - Trusted Information Security Assessment Exchange
6 source controls mapped|4 target controls covered
5%
PSD2 SCA
6 source controls mapped|3 target controls covered
5%
Open Banking Security
6 source controls mapped|3 target controls covered
5%
O-RAN WG11 Security Specification
6 source controls mapped|4 target controls covered
5%
Monetary Authority of Singapore Technology Risk Management Guidelines
6 source controls mapped|3 target controls covered
5%
FDA Quality Management System Regulation (QMSR)
6 source controls mapped|5 target controls covered
5%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
6 source controls mapped|6 target controls covered
5%
IAIS Insurance Core Principles (ICPs)
6 source controls mapped|3 target controls covered
5%
FFIEC IT Examination Handbook
6 source controls mapped|5 target controls covered
5%
IEC 60601-1 - Medical Electrical Equipment Safety
6 source controls mapped|4 target controls covered
5%
ISO 22320:2018
6 source controls mapped|4 target controls covered
5%
PCI SSF
6 source controls mapped|5 target controls covered
5%
PCI PIN Security
6 source controls mapped|5 target controls covered
5%
NIST Cybersecurity Framework 2.0
6 source controls mapped|6 target controls covered
5%
PCI P2PE
6 source controls mapped|5 target controls covered
5%
ISO/IEC 23894:2023
6 source controls mapped|6 target controls covered
5%
ISO 28001:2007 Supply Chain Security Management
6 source controls mapped|2 target controls covered
5%
Kuwait National Cybersecurity Framework
6 source controls mapped|2 target controls covered
5%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
6 source controls mapped|5 target controls covered
5%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
6 source controls mapped|2 target controls covered
5%
SASB Standards
5 source controls mapped|6 target controls covered
4%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
5 source controls mapped|2 target controls covered
4%
NIST Privacy Framework
5 source controls mapped|3 target controls covered
4%
NERC CIP
5 source controls mapped|2 target controls covered
4%
ITAR - International Traffic in Arms Regulations
5 source controls mapped|2 target controls covered
4%
IEEE 1686
5 source controls mapped|2 target controls covered
4%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
5 source controls mapped|4 target controls covered
4%
FedRAMP Rev 5
5 source controls mapped|4 target controls covered
4%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
5 source controls mapped|3 target controls covered
4%
API 1164
5 source controls mapped|4 target controls covered
4%
ISO/IEC 27014:2020
5 source controls mapped|3 target controls covered
4%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
5 source controls mapped|2 target controls covered
4%
ISO/IEC 27400:2022
5 source controls mapped|2 target controls covered
4%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
5 source controls mapped|4 target controls covered
4%
IEC 62443
5 source controls mapped|4 target controls covered
4%
NIST SP 800-53 Rev 5
5 source controls mapped|7 target controls covered
4%
ISO/IEC 27019:2024
5 source controls mapped|4 target controls covered
4%
NIST SP 1800-32
5 source controls mapped|4 target controls covered
4%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
5 source controls mapped|5 target controls covered
4%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
5 source controls mapped|2 target controls covered
4%
Automotive SPICE (ASPICE) v4.1 - Process Assessment Model
5 source controls mapped|3 target controls covered
4%
ISO 41001:2018 - Facility Management Systems
5 source controls mapped|3 target controls covered
4%
ISO 56002
5 source controls mapped|3 target controls covered
4%
AICPA Privacy Management Framework (PMF)
5 source controls mapped|2 target controls covered
4%
FTC GLBA Safeguards Rule (16 CFR Part 314)
5 source controls mapped|2 target controls covered
4%
SOC 2
5 source controls mapped|3 target controls covered
4%
ISO 9001:2015
4 source controls mapped|5 target controls covered
3%
NIST SP 800-39
4 source controls mapped|2 target controls covered
3%
NIST SP 800-37
4 source controls mapped|2 target controls covered
3%
NIST SP 800-30
4 source controls mapped|3 target controls covered
3%
German Supply Chain Due Diligence Act (LkSG)
4 source controls mapped|2 target controls covered
3%
BSI IT-Grundschutz
4 source controls mapped|3 target controls covered
3%
AS9100D - Aerospace Quality Management System
4 source controls mapped|2 target controls covered
3%
Aged Care Quality Standards 2019 (repealed edition)
4 source controls mapped|2 target controls covered
3%
EASA Part-IS - Information Security in Aviation
4 source controls mapped|4 target controls covered
3%
ISO/IEC 20000-1:2018
4 source controls mapped|2 target controls covered
3%
ITIL 4
4 source controls mapped|2 target controls covered
3%
ISO 30401
4 source controls mapped|2 target controls covered
3%
PCI DSS 4.0
4 source controls mapped|3 target controls covered
3%
ISO/IEC 25012:2008 - Data Quality Model
4 source controls mapped|3 target controls covered
3%
ISO/IEC/IEEE 29148:2018 - Systems and Software Engineering - Requirements Engineering
4 source controls mapped|7 target controls covered
3%
UK AI Regulation Framework
3 source controls mapped|1 target controls covered
2%
SEC Climate Disclosure Rule
3 source controls mapped|1 target controls covered
2%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
3 source controls mapped|1 target controls covered
2%
OECD Recommendation on Artificial Intelligence (2024 Update)
3 source controls mapped|1 target controls covered
2%
OECD AI Principles
3 source controls mapped|2 target controls covered
2%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
3 source controls mapped|2 target controls covered
2%
New Zealand Information Security Manual (NZISM)
3 source controls mapped|1 target controls covered
2%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
3 source controls mapped|1 target controls covered
2%
Japan AI Guidelines
3 source controls mapped|3 target controls covered
2%
IRM/AIRMIC/ALARM A Risk Management Standard (2002)
3 source controls mapped|1 target controls covered
2%
IEEE 7000
3 source controls mapped|2 target controls covered
2%
ICAO Annex 17 - Aviation Security (AVSEC)
3 source controls mapped|2 target controls covered
2%
FFIEC Cybersecurity Assessment Tool (CAT)
3 source controls mapped|3 target controls covered
2%
APRA CPS 234
3 source controls mapped|2 target controls covered
2%
BS 65000:2014 - Guidance on Organizational Resilience
3 source controls mapped|2 target controls covered
2%
SQF Code Edition 9 - Safe Quality Food
3 source controls mapped|2 target controls covered
2%
AML/CTF Act 2006 (Australia)
3 source controls mapped|1 target controls covered
2%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
3 source controls mapped|1 target controls covered
2%
Singapore AI Governance Framework
3 source controls mapped|2 target controls covered
2%
APRA CPS 230 Operational Risk Management
3 source controls mapped|3 target controls covered
2%
FBI CJIS Security Policy
3 source controls mapped|2 target controls covered
2%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|3 target controls covered
2%
Solvency II
3 source controls mapped|3 target controls covered
2%
APRA SPS 220 Risk Management (Superannuation)
3 source controls mapped|1 target controls covered
2%
Telecommunications Sector Security Reforms (TSSR)
3 source controls mapped|1 target controls covered
2%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|1 target controls covered
2%
ISO 22000:2018
3 source controls mapped|2 target controls covered
2%
WCAG 2.2
3 source controls mapped|1 target controls covered
2%
UK Gambling Commission LCCP and Remote Technical Standards
3 source controls mapped|2 target controls covered
2%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|1 target controls covered
2%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
3 source controls mapped|1 target controls covered
2%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
2%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|3 target controls covered
2%
Tanzania Personal Data Protection Act 2022
3 source controls mapped|2 target controls covered
2%
SLSA
3 source controls mapped|1 target controls covered
2%
SIG (Shared Assessments)
3 source controls mapped|1 target controls covered
2%
PTES
3 source controls mapped|1 target controls covered
2%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
2%
OWASP SAMM
3 source controls mapped|1 target controls covered
2%
OWASP MASVS
3 source controls mapped|1 target controls covered
2%
OpenSSF Scorecard
3 source controls mapped|1 target controls covered
2%
Notifiable Data Breaches Scheme (Australia)
3 source controls mapped|1 target controls covered
2%
NIST SP 800-92
3 source controls mapped|1 target controls covered
2%
NIST SP 800-88
3 source controls mapped|1 target controls covered
2%
NIST SP 800-63-4
3 source controls mapped|1 target controls covered
2%
NIST SP 800-61 Rev. 3
3 source controls mapped|1 target controls covered
2%
NIST SP 800-137
3 source controls mapped|1 target controls covered
2%
NIST SP 800-123
3 source controls mapped|1 target controls covered
2%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
3 source controls mapped|1 target controls covered
2%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|3 target controls covered
2%
Nebraska Data Privacy Act
3 source controls mapped|3 target controls covered
2%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
3 source controls mapped|2 target controls covered
2%
MITRE ATT&CK
3 source controls mapped|1 target controls covered
2%
South Korea PIPA
3 source controls mapped|1 target controls covered
2%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
2%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|2 target controls covered
2%
IATA Operational Safety Audit (IOSA) Standards Manual
3 source controls mapped|1 target controls covered
2%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|1 target controls covered
2%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|2 target controls covered
2%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
3 source controls mapped|1 target controls covered
2%
ISO/IEC 29147:2018
3 source controls mapped|2 target controls covered
2%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
2%
ISO/IEC 23837:2023
3 source controls mapped|1 target controls covered
2%
FedRAMP High
3 source controls mapped|1 target controls covered
2%
FedRAMP Moderate
3 source controls mapped|1 target controls covered
2%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|1 target controls covered
2%
ISO/IEC 29134:2023
3 source controls mapped|1 target controls covered
2%
IEC 62351 - Power Systems Communication Security
3 source controls mapped|1 target controls covered
2%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
2%
Connecticut Data Privacy Act (CTDPA)
3 source controls mapped|1 target controls covered
2%
COBIT 2019
3 source controls mapped|1 target controls covered
2%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
2%
ISO/IEC 27011:2024
3 source controls mapped|2 target controls covered
2%
ISO/IEC 29115:2013 - Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
2%
ISO/IEC 27031:2011
3 source controls mapped|1 target controls covered
2%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
3 source controls mapped|2 target controls covered
2%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
2%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
2%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
2%
Albania Law No. 124/2024 on Personal Data Protection
3 source controls mapped|2 target controls covered
2%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
3 source controls mapped|1 target controls covered
2%
ISO/IEC 27050-1:2019
3 source controls mapped|1 target controls covered
2%
ASIS SPC.1-2009 - Organizational Resilience Standard
3 source controls mapped|1 target controls covered
2%
ISO/IEC 30111:2019
3 source controls mapped|2 target controls covered
2%
DFARS 252.204-7012 - Safeguarding Covered Defense Information
3 source controls mapped|1 target controls covered
2%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
2%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
2%
SANS Incident Handler's Handbook and PICERL Methodology
3 source controls mapped|2 target controls covered
2%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
3 source controls mapped|3 target controls covered
2%
US SEC Digital Assets and Crypto Regulatory Framework
3 source controls mapped|2 target controls covered
2%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
2%
Singapore Cybersecurity Act 2018
3 source controls mapped|1 target controls covered
2%
ISO 8000 - Data Quality
3 source controls mapped|2 target controls covered
2%
UK Open Banking Standard
3 source controls mapped|1 target controls covered
2%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
2%
ISO/SAE 21434
3 source controls mapped|1 target controls covered
2%
ISO/IEC 27043:2015
3 source controls mapped|1 target controls covered
2%
UK Telecommunications (Security) Act 2021
3 source controls mapped|1 target controls covered
2%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|1 target controls covered
2%
Voluntary Principles on Security and Human Rights (VPs)
2 source controls mapped|1 target controls covered
2%
UK FCA/PRA Operational Resilience Framework
2 source controls mapped|1 target controls covered
2%
Secure by Design: A Guide for Manufacturers (CISA)
2 source controls mapped|1 target controls covered
2%
SA8000:2014 - Social Accountability Standard
2 source controls mapped|1 target controls covered
2%
Oman National Cybersecurity Framework
2 source controls mapped|1 target controls covered
2%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
2 source controls mapped|1 target controls covered
2%
ASD Strategies to Mitigate Cyber Security Incidents
2 source controls mapped|3 target controls covered
2%
Canada ITSG-33 - IT Security Risk Management
2 source controls mapped|1 target controls covered
2%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
2 source controls mapped|2 target controls covered
2%
ISO 45001:2018
2 source controls mapped|1 target controls covered
2%
ISO 39001:2012 - Road Traffic Safety Management
2 source controls mapped|1 target controls covered
2%
ISO 13485:2016
1 source controls mapped|1 target controls covered
1%
21 CFR Part 211 - Current Good Manufacturing Practice
1 source controls mapped|3 target controls covered
1%
21 CFR Part 58 - Good Laboratory Practice (GLP)
1 source controls mapped|1 target controls covered
1%
Coverage is not the same as your position
This page shows what IEC 62304:2015 Medical Device Software Lifecycle Processes overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.
The Compliance Position Diagnostic, $5,000 fixed, ten business daysWhat is IEC 62304:2015 Medical Device Software Lifecycle Processes and who does it apply to?
IEC 62304:2015 Medical Device Software Lifecycle Processes is a compliance framework from International (IEC); harmonised as EN 62304 under the EU MDR; FDA recognised consensus standard; adopted as ANSI/AAMI/IEC 62304 and nationally with 6 domains and 99 controls. The IEC standard for medical device software life cycle processes, built from the complete Edition 1.1 text (2006 with Amendment 1:2015): 99 requirement leaves across development, maintenance, risk management, configuration management and problem resolution, each marked with the software safety classes A, B and C it applies to. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does IEC 62304:2015 Medical Device Software Lifecycle Processes actually require?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 99 controls organised across 6 domains. The largest domains are Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes (54 controls), Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes (13 controls), Clause 4: general requirements (quality system, risk management, safety classification, legacy software) – IEC 62304:2015 Medical Device Software Lifecycle Processes (8 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of IEC 62304:2015 Medical Device Software Lifecycle Processes do I already cover?
IEC 62304:2015 Medical Device Software Lifecycle Processes maps to 194 other compliance frameworks. The top mapping partners are EN 50716:2023 - Railway Applications - Requirements for Software Development (31% coverage), GAMP 5 - Good Automated Manufacturing Practice (10% coverage), ICH Q10 - Pharmaceutical Quality System (7% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I implement IEC 62304:2015 Medical Device Software Lifecycle Processes?
Start your IEC 62304:2015 Medical Device Software Lifecycle Processes compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about IEC 62304:2015 Medical Device Software Lifecycle Processes requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 99 controls and track your progress.
Start Your Compliance Journey
Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 1,120 frameworks.
Get Started Free →Free forever, no credit card required