International (IEC); harmonised as EN 62304 under the EU MDR; FDA recognised consensus standard; adopted as ANSI/AAMI/IEC 62304 and nationally

IEC 62304:2015 Medical Device Software Lifecycle Processes

158 controls. 208 other frameworks in our corpus share controls with it. Here is all of it, and how much of it you are already doing.

Page built . This page is derived from the framework corpus, which changes when the corpus is extended rather than daily.

158 controls 208 frameworks share controls with it International (IEC); harmonised as EN 62304 under the EU MDR; FDA recognised consensus standard; adopted as ANSI/AAMI/IEC 62304 and nationally verified against its source document

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

There is no implementation kit for this framework yet. The control list and the overlap above are free and complete.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you runShared controls
ICH Q109measure it →
Annex 11 to EU GMP8measure it →
MTCS (Singapore)8measure it →
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security8measure it →
SSAE 188measure it →
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)7measure it →
ISMAP (Japan)7measure it →
ISO 15189:20227measure it →
ISO 190117measure it →
ISO 20400:20177measure it →
ISO 26262:20187measure it →
ISO 270177measure it →

Every control

CodeControlAlso in
IEC62304-4.1Quality Management System125
IEC62304-4.2Risk Management0
IEC62304-4.3Software Safety Classification0
IEC62304-4.4Legacy Software0
IEC62304-5.1Software Development Planning106
IEC62304-5.1.1Software Development Plan0
IEC62304-5.1.6SOUP Identification0
IEC62304-5.2Software Requirements Analysis138
IEC62304-5.3Software Architectural Design138
IEC62304-5.4Software Detailed Design0
IEC62304-5.5Software Unit Implementation and Verification0
IEC62304-5.6Software Integration and Testing0
IEC62304-5.7Software System Testing0
IEC62304-5.8Software Release0
IEC62304-6.1Software Maintenance Plan0
IEC62304-6.2Problem and Modification Analysis0
IEC62304-6.3Modification Implementation0
IEC62304-7.1Risk Analysis of Software Contributing to Hazardous Situations0
IEC62304-7.2Risk Control Measures138
IEC62304-7.3Verification of Risk Control Measures1
IEC62304-7.4Risk Management of Software Changes79
IEC62304-8.1Configuration Identification0
IEC62304-8.2Change Control37
IEC62304-8.3Configuration Status Accounting0
IEC62304-9Software Problem Resolution Process0
IEC62304-9.1Prepare Problem Reports0
IEC62304-9.2Investigate the Problem0
IEC62304-9.3Advise Relevant Parties0
IEC62304-9.4Use Change Control Process36
IEC62304-9.5Maintain Records0
IEC62304-9.6Analyze Problems for Trends40
IEC62304-9.7Verify Software Problem Resolution0
IEC62304-9.8Test Documentation0
44 General requirements0
4.14.1 Quality management system0
4.24.2 Risk management0
4.34.3 Software safety classification0
4.44.4 Legacy software0
4.4.14.4.1 General0
4.4.24.4.2 Risk management activities0
4.4.34.4.3 Gap analysis0
4.4.44.4.4 Gap closure activities0
4.4.54.4.5 Rationale for use of legacy software0
55 Software development process0
5.15.1 Software development planning0
5.1.15.1.1 Software development plan0
5.1.105.1.10 Supporting items to be controlled0
5.1.115.1.11 Software configuration item control before verification0
5.1.125.1.12 Identification and avoidance of common software defects0
5.1.25.1.2 Keep software development plan updated0
5.1.35.1.3 Software development plan reference to system design and development0
5.1.45.1.4 Software development standards, methods and tools planning0
5.1.55.1.5 Software integration and integration testing planning0
5.1.65.1.6 Software verification planning0
5.1.75.1.7 Software risk management planning0
5.1.85.1.8 Documentation planning0
5.1.95.1.9 Software configuration management planning0
5.25.2 Software requirements analysis0
5.2.15.2.1 Define and document software requirements from system requirements0
5.2.25.2.2 Software requirements content0
5.2.35.2.3 Include risk control measures in software requirements0
5.2.45.2.4 Re-evaluate medical device risk analysis0
5.2.55.2.5 Update system requirements0
5.2.65.2.6 Verify software requirements0
5.35.3 Software architectural design0
5.3.15.3.1 Transform software requirements into an architecture0
5.3.25.3.2 Develop an architecture for the interfaces of software items0
5.3.35.3.3 Specify functional and performance requirements of SOUP item0
5.3.45.3.4 Specify system hardware and software required by SOUP item0
5.3.55.3.5 Identify segregation necessary for risk control0
5.3.65.3.6 Verify software architecture0
5.45.4 Software detailed design0
5.4.15.4.1 Subdivide software into software units0
5.4.25.4.2 Develop detailed design for each software unit0
5.4.35.4.3 Develop detailed design for interfaces0
5.4.45.4.4 Verify detailed design0
5.55.5 Software unit implementation and verification0
5.5.15.5.1 Implement each software unit0
5.5.25.5.2 Establish software unit verification process0
5.5.35.5.3 Software unit acceptance criteria0
5.5.45.5.4 Additional software unit acceptance criteria0
5.5.55.5.5 Software unit verification0
5.65.6 Software integration and integration testing0
5.6.15.6.1 Integrate software units0
5.6.25.6.2 Verify software integration0
5.6.35.6.3 Software integration testing0
5.6.45.6.4 Software integration testing content0
5.6.55.6.5 Evaluate software integration test procedures0
5.6.65.6.6 Conduct regression tests0
5.6.75.6.7 Integration test record contents0
5.6.85.6.8 Use software problem resolution process0
5.75.7 Software system testing0
5.7.15.7.1 Establish tests for software requirements0
5.7.25.7.2 Use software problem resolution process0
5.7.35.7.3 Retest after changes0
5.7.45.7.4 Evaluate software system testing0
5.7.55.7.5 Software system test record contents0
5.85.8 Software release0
5.8.15.8.1 Ensure software verification is complete0
5.8.25.8.2 Document known residual anomalies0
5.8.35.8.3 Evaluate known residual anomalies0
5.8.45.8.4 Document released versions0
5.8.55.8.5 Document how released software was created0
5.8.65.8.6 Ensure activities and tasks are complete0
5.8.75.8.7 Archive software0
5.8.85.8.8 Assure reliable delivery of released software0
66 Software maintenance process0
6.16.1 Establish software maintenance plan0
6.26.2 Problem and modification analysis0
6.2.16.2.1 Document and evaluate feedback0
6.2.26.2.2 Use software problem resolution process0
6.2.36.2.3 Analyse change requests0
6.2.46.2.4 Change request approval0
6.2.56.2.5 Communicate to users and regulators0
6.36.3 Modification implementation0
6.3.16.3.1 Use established process to implement modification0
6.3.26.3.2 Re-release modified software system0
77 Software risk management process0
7.17.1 Analysis of software contributing to hazardous situations0
7.1.17.1.1 Identify software items that could contribute to a hazardous situation0
7.1.27.1.2 Identify potential causes of contribution to a hazardous situation0
7.1.37.1.3 Evaluate published SOUP anomaly lists0
7.1.47.1.4 Document potential causes0
7.1.57.1.5 Document sequences of events0
7.27.2 Risk control measures0
7.2.17.2.1 Define risk control measures0
7.2.27.2.2 Risk control measures implemented in software0
7.37.3 Verification of risk control measures0
7.3.17.3.1 Verify risk control measures0
7.3.27.3.2 Document any new sequences of events0
7.3.37.3.3 Document traceability0
7.47.4 Risk management of software changes0
7.4.17.4.1 Analyse changes to medical device software with respect to safety0
7.4.27.4.2 Analyse impact of software changes on existing risk control measures0
7.4.37.4.3 Perform risk management activities based on analyses0
88 Software configuration management process0
8.18.1 Configuration identification0
8.1.18.1.1 Establish means to identify configuration items0
8.1.28.1.2 Identify SOUP0
8.1.38.1.3 Identify system configuration documentation0
8.28.2 Change control0
8.2.18.2.1 Approve change requests0
8.2.28.2.2 Implement changes0
8.2.38.2.3 Verify changes0
8.2.48.2.4 Provide means for traceability of change0
8.38.3 Configuration status accounting0
99 Software problem resolution process0
9.19.1 Prepare problem reports0
9.29.2 Investigate the problem0
9.39.3 Advise relevant parties0
9.49.4 Use change control process0
9.59.5 Maintain records0
9.69.6 Analyse problems for trends0
9.79.7 Verify software problem resolution0
9.89.8 Test documentation contents0
ANNEXESAnnexes A to D: rationale, guidance, relationship to other standards, implementation0
SCOPEClauses 1 to 3: scope, compliance, normative references and terms0
STANDARDIEC 62304: the standard, Amendment 1:2015, the second edition in preparation and what is held0

Tell me when IEC 62304:2015 Medical Device Software Lifecycle Processes files something new

One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.

What an auditor will ask you to produce

The artefacts named on the failure modes this framework speaks to.

  • Verification procedures
  • Verification reports
  • Sign-off records
  • Complaints register
  • Appeals process
  • Independent review records

How programmes fail on this

Failure modes named by this framework and others. Each opens the full record.

What this page is

A control-level reference for IEC 62304:2015 Medical Device Software Lifecycle Processes, drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

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