Medical Software

Engineering Template
Compliance support for EU MDR and US FDA regulations and
applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and
FDA T21 CFR Part 11 & 820
 Medical Software Engineering Template

The Medical Software

Engineering Template
As a developer of medical technology, you are likely facing a twofold challenge in today’s digital
healthcare economy. On one hand, due to increasing regulatory scrutiny, you need to enhance
the quality of your products (as well as overall organizational excellence). Market pressure from
competitors, on the other hand, pushes you to increase your speed of product delivery. Established
best practices are immensely valuable in connecting and achieving those goals in the development
of medical technology.

This Medical Software Engineering Template enables you to adopt best practices for medical
software development with minimal effort. This template contains baked-in domain knowledge and
processes that leverage industry best practices, inherently providing conformance to regulatory
requirements in the European Union and United States markets.

In addition to being predefined for regulatory compliance, this template provides user-focused and
practical information to walk users through a fully compliant delivery process for medical technology
software. The template’s wiki, artifacts, processes, and documents may be easily understood through
the example of a glucose meter development project demonstrated in this template.

SCOPE
This Medical Software Engineering Template focuses on:

Medical software
Software as a
development for Software as part of an
mobile medical
software as a stand- embedded system
application
alone medical device
 Medical Software Engineering Template

Why use this Medical Software Engineering Template?

Streamline compliance with regulatory requirements in the development of medical devices & digital
healthcare technology.

1 2 3 4

Fully customizable Shorter route to value Medical compliance Integrated quality

Adapt preconfigured Use this template out of Use an all-in-one hub management
artifacts and processes the box to implement to manage all your Automate process
to your needs. Customize a fully compliant technical content for control in medical
the template for a development project. CE marking & US FDA software development
tailor-made solution for Reduce effort, costs, and market access reviews. to avoid deviations.
development support time to market. Rely on compliance Connect quality control
and compliance. support for EU MDR/ and audit management
IVDR (Class I to III), IEC using the Medical Audit
62304, ISO14971, ISO & CAPA Template.
13485, FDA Title 21 CFR
Part 11 & Part 820, IEC
82304-1.
 Medical Software Engineering Template

Capabilities of the Medical Software

Engineering Template
Requirements Engineering

Requirements Engineering is an integrated part of this

Medical Software Engineering Template. You’ll find
predefined artifacts to manage product architecture,
user requirements, system requirements, design
specifications, and more. The template lets you manage
product risk-related requirements on multiple levels,
including non-software related items (such as packaging
and labeling requirements). All these requirements are
interconnected with references to guarantee traceability.

Change Management

Once you have an approved budget, feature

development can start. To support transparent
development in an Agile setting, this template provides Change Requests artifacts. By default, these items
may be easily referenced to Planned Product Releases, Tasks, or User Requirements – but you can easily
adapt these relations to your needs. Change Request items also provide data fields for product risk impact
assessment. Any and all changes on all your work items are automatically recorded and may be reviewed at
any time.
Medical Software Engineering Template

Support from Development to

Release

This Medical Software Engineering

Template supports an integrated approach
to medical software development. End-
to-end traceability is easily achieved, and
you can simply compile custom traceability
queries in the Traceability Browser.
Predefined queries help you answer
typical traceability-related questions with
minimal effort. Using this template, you
can manage the development of medical
software (including risks) from idea all the
way to release while complying with the
information and process requirements
of IEC 62304:2006 with its latest (2015)
amendments, IEC 82304-1, and ISO
14971:2012.

Lifecycle Product
Risk Management

This template helps your product risk

management activities throughout the
entire medical software development
lifecycle as per the normative part of ISO
14971. You can easily record, manage, and
track risks, and associate them to other
work items for risk traceability. Risk-related
data may be stored in dedicated trackers,
including risk analysis information and
“information access” data. You can manage
risks together with risk control measures to
enable insights into the overall risk levels of
your products.

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 Medical Software Engineering Template

Documentation Technical File &

Management Design History File

Using configurable export templates, you can easily This Medical Software Engineering Template
export all data stored in the Design Control, Product supports the compilation of a Technical File or a
Risk Management, and Verification and Validation Design History File. Any and all engineering content
artifacts to Office documents. Similarly, content and processes (entered, maintained, or archived in
stored externally in documents may be easily the system) can be simply collected and organized
imported into trackers. You can rely on sophisticated to produce a comprehensive Technical File or DHF.
review processes for your documents using the You can also easily incorporate external content into
Review Hub, and timestamped, Part 11-compliant these repositories, and verify them with compliant
e-signatures may be used for the review & approval electronic signatures. Any information stored outside
for all items including documents. of this template may be easily imported.

Medical Software Engineering Template

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Medical Software Engineering Template

Design Control Verification & Validation

The Medical Software Engineering Template was This template supports effective, traceable, and
developed to support the lifecycle-wide design reportable product verification and validation
control processes of MedTech software. You can activities. Predefined protocols, test data, and
easily integrate organization-specific practices established relationships between items help you
into this template, enabling medical software manage verification and validation on multiple levels.
development organizations to tailor the template to Artifacts are available for system validation, software-
their needs. Processes may be enforced via guards, hardware verification integration, software unit
e-signatures, and other workflow practices to avoid verification etc, with traceability guaranteed across
deviations. them.
 Medical Software Engineering Template

Vigilance and Post-Market Surveillance

To help you adhere to the requirements of EU MDR’s Annex III on Post-Market Surveillance, this
template provides a dedicated information container. Market recall and adverse incident reports from
the US FDA and EU Local Authorities can easily be imported to provide a solid foundation for market
vigilance and market surveillance activities. Pro tip: Codebeamer’s Medical Audit & CAPA Template
takes this even a step further, offering Customer Complaint and Feedbacks, CAPA content, and
Adverse Incident Reporting.

SOUP and Legacy Software Management

The standard IEC 62304:2006/AMD1:2015 distinguishes between two types of externally sourced
software used in medical software development: Software Of Unknown Provenance (SOUP) and
Legacy Software. This template provides dedicated information containers and preset traceability
rules in its SOUP artifacts to provide compliance evidence. The template also offers preconfigured
capability and items to capture information on Legacy Software in order to support compliance with
the measures, considerations, and requirements set forth by IEC 62304:2006/AMD1:2015.

Quality Management for Medical Devices

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 Intland's built-in functionality
C onfi gurati on D oc ument SCM Tra c e a b i l i t y V&V R oadmap
Tra c k e rs W iki R eports
Items Management R epos i tori es B row s er Management Manager

IE C 8 2 3 0 4 -1 :2 0 1 6 : H e a lth s o ftw a re – P a rt 1 : G e n e ra l re q u ire m e n ts fo r p ro d u c t s a fe ty

Health Software Product Requirements
General requirements and initial Risk Assessment + + + + + + + +
Health Software Product use requirements + + + + +
Verification of Health Software Product use requirements + + + +
Updating Health Software Product use requirements + + + + +
System requirements + + + +
Verification of system requirements + + + + + +
Updating Health Software Product system requirements + + + + +
Health Software – Software Life Cycle Processes See evaluation for IEC 62304:2006
Health Software Product Validation
Validation plan + +
Performing validation + + +
Validation report + +
Health Software Product Identification and Accompanying Documents
Identification + + + + +
Instructions for use +
Technical description +
Post-market Activities for the Health Software Product
Software Maintenance + + + +
Re-validation + + + + +
Post-market communication on the Health Software Product + + +
Decommissioning and disposal of the Health Software Product + +
IE C 6 2 3 0 4 :2 0 0 6 : M e d ic a l d e v ic e s o ftw a re - S o ftw a re life c y c le p ro c e s s e s
General Requirements
Quality management system + + +
Risk Management + + + + + + + + +
Software safety classification + +
Software Development Process
Software development planning + + +
Software requirements analysis + + + +
Software architectural design + + +
Software detailed design + + +
Software unit implementation and verification + + + + + +
Software integration and integration testing + + + +
Software system testing + + + + +
Software release + + + +
Software Maintenance Process
Establish software maintenance plan + +
Problem and modification analysis + +
Modification implementation + + + + +
Software Risk Management process
Analysis of software contributing to hazardous situations + + + +
Risk Control measures + + + +
Verification of Risk Control measures + + + + +
Risk Management of software changes + + + + +
Software configuration management process
Configuration identification + + + + +
Change control + + + +
Configuration status accounting + +
Software problem resolution Process
Prepare problem reports + + +
Investigate the problem + + + +
Advise relevant parties + +
Use change control process + + + +
Maintain records + + + +
Analyse problems for trends + + + +
Verify software problem resolution + +
Test documentation contents + + + + +
E N IS O 1 4 9 7 1 :2 0 1 2 : M e d ic a l d e v ic e s — A p p lic a tio n o f ris k m a n a g e m e n t to m e d ic a l d e v ic e s
General requirements for risk management
Risk management process + + + + +
Management responsibilities + +
Qualification of personnel + +
Risk management plan + +
Risk management file + + + + + + +
Risk analysis
Risk analysis process + + + +
Intended use and identification of characteristics related to the + + +
Identification of hazards + + +
Estimation of the risk(s) for each hazardous situation + + +
Risk evaluation + + + +
Risk control
Risk reduction + + +
Risk control option analysis + + +
Implementation of risk control measure(s) + + +
Residual risk evaluation + + +
Risk/benefit analysis + + + +
Risks arising from risk control measures + + + + +
Completeness of risk control + + + + + +
Evaluation of overall residual risk acceptability + + + + +
 Medical Software Engineering Template

Templates

Start quickly and accelerate your ROI using preconfigured templates. Templates are easy to use, and you can
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Medical Software Engineering Template

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world’s largest medical technology company reaches
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 Validation Kits

Codebeamer’s Validation Kits are valuable tools for safety-critical product development teams with
regulatory compliance needs.

• Tool Validation Kit • Title 21 CFR Part 11 Validation Kit

Use this kit to simplify and accelerate tool Rely on this tool to prove compliance with
qualification and validation in regulated product 21CFR11 requirements about electronic records
development. management.