Software as a Medical Device: SaMD Regulations

Description

• Medical-use software that operates independently of other equipment (stand-alone medical software)
• Software used in conjunction with [but functioning separately to] other medical devices
• Software/apps with complementary medical functions (e.g., radiotherapy guides that assist with drug delivery targets/treatment planning yet which do not rely on the delivery equipment, e.g. these products operate separately to the equipment)
• Software with diagnostic assistance functionality and/or dose management capacity

Why take this course?

Compliance and Regulatory Expectations

Participants will gain an understanding of:

• SaMD compliance requirements, including computer system validation (CSV)
• Relevant medical device regulations (e.g., EU MDR, FDA, TGA, EMA, MHRA)
• Industry standards such as IMDRF guidance on SaMD risk categorization
• Industry standards including IEC 62304
• Auditing trends and regulatory authority expectations
• Quality control measures to mitigate software-related risks

 

 

Who Should Enroll?

This course is designed for:

• Engineers, software designers, and IT professionals in the medical device industry
• Medical software developers and programmers
• Quality management personnel
• Compliance officers/regulatory affairs professionals
• Regulatory Compliance Inspectors/Regulatory Authorities
• Healthcare practitioners using medical device software
• Clinical researchers and hospital software suppliers

Key Learning Areas

Participants will learn about:

• SaMD classification and regulatory frameworks (IMDRF, FDA, TGA, EMA, MHRA)
• Differences between stand-alone SaMD and embedded software
• Quality management system (QMS) considerations for SaMD
• Software risk classifications, e.g., from industry publications and IEC 62304
• Cybersecurity risks, data integrity, and regulatory expectations
• Good Manufacturing Practice (GMP) compliance for medical-use software
• Risk management strategies and software validation processes
• Documentation requirements (across software/SaMD product lifecycle)

• SaMD Software Classifications & Types 
  • Different types of medical-use software and their risk classifications
  • SaMD vs. Non-SaMD: Which software products are classified as Software as a Medical Device (SaMD)
  • Differences between SaMD, embedded software (firmware), and health-related software (e.g., FitBits)
  • Which software products are regulated separately from other medical-purpose software
• SaMD Regulatory Framework & Compliance
  • SaMD regulations & guidelines (IMDRF, Australia, U.S., Europe, UK)
  • Harmonization efforts for SaMD regulatory compliance by the IMDRF
  • GMP regulations for medical-purpose software and EIC 62304
  • ISO 13485 (QMS) and ISO 14971 (Quality Risk Management) compliance requirements
  • How different countries regulate medical-use software (Australia, U.S., Europe, UK)
• Quality Management & Risk Controls for Software as a Medical Device
  • Quality Risk Management (QRM) for medical software
  • Quality control measures to reduce risks, including:
    • User error
    • Data integrity issues
    • Coding errors
  • Design & development of quality controls
  • Documentation requirements: validation, post-release monitoring
• SaMD Applications & Emerging Trends
  • mHealth and the medical-use software industry
  • SaMD in diagnostics, remote monitoring, and clinical decision-making
    • Chronic condition monitoring
    • Prescription dosing regulation
    • AI-assisted medical decision support
• Software Risks & Cybersecurity
  • Medical industry software risks, including:
    • Cybersecurity threats
    • Data breaches
    • Malware attacks
    • Compatibility between hardware/firmware/software
  • Legal obligations & quality assurance responsibilities for SaMD suppliers
  • The importance of a robust QMS using risk-management principles

Why learn SaMD regulatory compliance?

Software with medical functionality must meet stringent development, manufacturing and product testing standards.

Medical software is rapidly increasing in complexity, scope, and centrality to patient care decisions. As everyone working with computerised systems — including medical software — is well aware, software products generally require:

• Testing and validation
• End-user instructions and training
• Data security measures/independent logins (cybersecurity)
• Updates/upgrades and other maintenance activities
• Firmware/software/technology replacements as appropriate (continuous improvements)

It is crucial that potential input errors, system faults, power outages and other risks of medical-use software are appropriately risk-assessed and mitigated through robust quality monitoring systems.

Course Benefits

• Understand legal obligations for SaMD compliance and related standards
• Gain insights into recordkeeping, safety monitoring, and regulatory audits
• Learn about international harmonization efforts for SaMD regulations
• Explore recent trends in medical software, including mHealth apps and AI-driven diagnostics

Quality by Design (QbD) is particularly important when it comes to medical device products, including medical software products.

Collaborations with clinicians should also begin early in the design stages; with continuous improvements continuing through the lifespan of the software product.

• This includes different types of regulated medical software – including customised software programs – used in medical clinics, hospitals, doctor’s offices, cancer treatment facilities, medical schools/universities, and other healthcare delivery or software device-testing facilities.
• This course, as part of a blended learning solution, helps software designers and SaMD personnel to better understand their legal obligations.
• It also helps medical equipment maintenance workers understand their regulatory compliance requirements.

SaMD regulations compliance orientation training for medical-purpose software personnel, maintenance contractors, and supply chain personnel/distributors:

• The SaMD regulations compliance (orientation training) course references guidelines from leading authorities
• These include the FDA, TGA, EMA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Why This Training Matters

This training provides a comprehensive understanding of SaMD regulations, quality risk management, and compliance expectations. It is suitable for professionals involved in medical software design, development, validation, and maintenance. Completing this course helps organizations mitigate risks and maintain regulatory compliance in the evolving medical software landscape.

This course aims to help learners gain knowledge of the legal compliance requirements that help:

• Ensure SaMD quality, safety and efficacy standards are met
• Encourage adequate quality/safety monitoring before, during, and after SaMD product development, including when:
  • Performing software updates
  • Maintaining medical-software products and/or testing these programs for reliability/accuracy
  • Overseeing software integration projects

As software increasingly becomes a crucial part of medical care, including determining oncology treatments and dosing regimes, the benefits and risks of medical use of software become more potent.

Course Format & SaMD Training Certificate

• Duration: 2 to 4 hours, including a final assessment
• Online format: Available 24/7 for 12 months post-purchase
• Certificate of Completion upon passing the final assessment

How to Enroll

1. Add the course to your basket and complete the purchase
2. Access is granted immediately via email login details
3. Course content is available for 12 months after purchase

For group training inquiries, visit the Contact Us page.

Summary

Regulatory compliance is crucial to ensure patient safety and avoid legal repercussions, fines, or manufacturing shutdowns. This course equips participants with the necessary knowledge to:

• Meet global SaMD regulatory requirements
• Ensure quality and safety in software development
• Stay updated with regulatory authority expectations

The SaMD regulations training course will generally benefit individuals who have a role in designing, developing, manufacturing, supplying, qualifying, validating, using and/or maintaining software products used for medical purposes (and/or software used in medical settings). This course will also help learners understand regulatory terminology relating to stand-alone medical software vs software embedded in a medical device.

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Learning Resources & Definitions

What is meant by SaMD when it comes to medical device software/programs?

• Medical-purpose software is a term that includes all software products that have stand-alone medical capacity or functions.
• Examples of SaMD include:
  • Software with health condition diagnosis or monitoring functionality
  • Software that provides medical treatment directives (radiation targets/dosing recommendations) or other critical parameters, e.g.
    • Dosing regimes
    • Treatment efficacy tracking
    • Other types/other healthcare functionality

Requirements for Software classified as a Medical Device (SaMD)

There are international standards for SaMD products, including IEC 62304: Medical Device Software – Software Life Cycle Processes. That noted, each jurisdiction may have its own regulatory approach to Software as Medical Device product types (and region-specific SaMD guidance publications).

This course provides a global perspective on SaMD regulatory compliance requirements.  Additionally, it includes examples of regulatory considerations for medical-use software (Sofware as a Medical Device or “SaMD“) from various groups and regulators, such as: the ICH, Europe (EMA), the UK (MHRA), the United States (FDA), and Australia (TGA).

These include Medical Device industry standards, such as ISO 13485 (QMS) and ISO 14971 (Quality Risk Management/QRM).

Read the article on FAQs for Medical-use software (SaMD).

How long does this SaMD compliance course take to complete?

• Completion timeframes for this training course generally range from 2 hours to 4 hours in total.
• This time frame includes the online Final Assessment regarding SaMD regulations compliance.
• Successful completion of the course, including the online Final Assessment, provides you with a SaMD course Certificate of Completion.

How do I get started?

• Add the course to your basket and then complete your purchase (check-out).
• Consider training bundles if you need multiple courses.
• Access is granted to this Software as a Medical Device (SaMD) course immediately upon ordering your course.
• Once you complete your online course purchase, simply search your email folders for your login information (search for “SaMD” or “onlinegmptraining”).
• You do not have to complete this course in one session.
• This course, and other courses you order, will be available to you via the internet, 24/7, for 12 months from the date of purchase.

Return to the online GMP training course listings, or scroll down to read further information about this training course.

Note: Use the ‘contact us’ page to request information on training a large number of employees.

SaMD compliance training is essential to help prevent product quality issues, regulatory inspection failures, audit-related citations/fines, and other product safety issues

This online SaMD GMP Regulations Compliance Training course is ideal for anyone working in the medical-use software sector. It is a particularly useful educational resource for manufacturing teams and software developers (coders and personnel tasked with maintaining software or updating medical-use software programs) and Quality Managers who design, maintain, and/or supply medical-purpose software to the healthcare sector.

The course is also targeted for professionals involved in SaMD quality assurance and quality risk management (QRM), CAPA investigations when there are serious adverse events (SAEs) or other harms to patients, and individuals working in software production/manufacturing, medical device product marketing, and product safety surveillance (e.g. pharmacovigilance for medical devices).

The online training course introduces learners to the specific SaMD regulations, good manufacturing practice (GMP) compliance requirements, and quality management systems (QMS)/Pharmaceutical Quality Systems (PQS) legal obligations that must be met when designing, sponsoring, and/or providing medical-use software (software-based medical devices) to healthcare markets or individual consumers.

Examples of who this medical-use software regulatory compliance training module is suitable for include but are not limited to the following:

• New and long-term employees needing GMP regulations compliance training for medical devices
• Medical software developers
• Manufacturing contractors and personnel
• Quality Managers and PQS responsible persons
• Diagnostic software end-users (medical teams) and clinical researchers using medical-purpose software
• Hospital software suppliers
• Medical-purpose software purchasers/purchasing teams
• Clinical trial personnel working with medical devices
• Medical professionals using diagnostic software or treatment planning software (TPS) systems for oncology treatments
• Other life science professionals including legal teams and manufacturing/sales administration personnel

Successful completion of the course provides learners with a Certificate of Completion for this compliance topic; which can be downloaded, printed, and attached to personnel training records and/or the person’s resume or job application form.

You can also use this SaMD regulations compliance course as a ‘refresher training course’

This Certificate GMP Course (available 24/7 online) not only makes an excellent induction course as part of blended-training programs, it can be used as a refresher course for regulatory compliance, e.g. for software product personnel.

 

• It should be combined with onsite training and product-specific training.
• Training modules are for educational purposes only.
• Online training is an adjunct to other training at your place of manufacture/product servicing; it does not, however, replace in-house training requirements and regulatory compliance expectations.

Pre-requisites for this online GMP training course:

It is recommended that learners understand Good Documentation Practice (GDocP principles). They should also have pre-existing training in Good Manufacturing Practice principles (GMP01), Good Recordkeeping Practice (GRP), and Pharmacovigilance (for reporting SAEs).