Software as a Medical Device (SaMD Regulations)

Software as a Medical Device (SaMD Regulations)


This SaMD regulations training course covers GMP regulations for software products designed for use in medical settings (medical-purpose software).

SaMD (Software as a Medical Device) means software that has stand-alone medical capacity. Examples include software with health condition diagnosis or monitoring functionality; and software that provides medical treatment directives or critical parameters such as pharmaceutical dosing regimes or treatment efficacy tracking.

This course covers GMP regulations for Software classified as a Medical Device (SaMD).

This Certificate GMP training course will introduce learners to the regulations, GMP compliance guidelines, and quality management considerations for developing and maintaining medical-use software.

This course includes examples of regulatory considerations for medical-use software (Sofware as a Medical Device or “SaMD“) from the ICH, Europe (EMA), the UK (MHRA), the United States (FDA), and Australia (TGA).

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

In this online course for SaMD regulations and compliance requirements, learners will be provided with information on:

  • Different types of software used in medicine
  • Embedded vs independently-operating medical-use software
  • Which software products are classified as SaMD
  • Which products and regulated separately to other types of medical-purpose software such as software embedded in, or dependent upon, a particular medical device (hardware/firmware)
  • Harmonisation efforts for SaMD by the IMDRF
  • GMP regulations for medical-purpose software
  • Quality control measures to reduce risks including user error, data integrity issues, coding errors
  • SaMD regulations including SaMD guidelines from the IMDRF
  • How different countries regulate medical use software (examples from Australia, America, Europe and the UK)
  • mHealth and the medical-use software industry
  • Classifications of software used for diagnostic purposes, or remote monitoring of chronic conditions or prescription dosing, clinical-treatment decision making aids
  • Quality Management System (QMS) considerations for software products (based on risks to patients)
  • Legal obligations and quality assurance responsibilities for SaMD suppliers
  • Medical industry software risks including cybersecurity, data breaches, and/or malware attacks

SaMD regulations training for medical-use software development training course

Average online training course completion time frame

GMP Certificate Course completion times can vary from person to person and from course to course.

  • Allow from 2.5 to 5 hours to complete this online SaMD training module, including the Final Assessment.
  • However, this is merely an estimate of the average time frame needed to complete this course including the Final Assessment.
  • Online GMP course completion times will vary from person to person and depend on numerous factors.
These factors include pre-existing knowledge and familiarity with the learning topic, individual learning styles and learning capacities, personal or professional time commitments, day-to-day and disruptions, internet speed and internet reliability, depth of topic content in each module, and many other factors.

SaMD medical-use software development training course for developers and SaMD regulations GMP compliance

How to purchase the SaMD regulations training course

  • Scroll up to add this purchase to your basket and then complete the check out process for this online course
  • Next, check your emails (including your filtered folders) for an email that contains your login details; this email should arrive to your email inbox fairly quickly (ensure you use your correct email address during the purchasing process)
  • If you don’t see this in your inbox, search your mailbox folders for ‘onlinegmptraining’ and/or ‘course’ and/or ‘SaMD’
  • Then use the log-in details to begin your Software as a Medical Device (SaMD) regulations training
  • You do not have to finish the training in one sitting
  • You will have access to the course for 12 months – one licence, one user, once Certificate per each module completed.

You can complete the course in multiple sittings or complete the training all at once. But you’ll gain access immediately upon completing your online purchase of the module. Single user licence only.  Access continues for 12 months from date of purchase.

For education purposes only.

The Certificate of Completion is not a statement of competence. However, it affirms you successfully completed the online SaMD training course and earned your training course Certificate.

  • This training is for education purposes only and is designed to supplement your specific onsite training, induction training and direct Supervision for SaMD development and medical device manufacturing regulation compliance in your workplace.
  • You can download, print and/or email your Certificate of Completion after successfully completing the final assessment of this certificate course (online).


SaMD regulations training course: is your team compliant with current regulations?

This Software as a Medical Device SaMD regulations training course covers GMP compliance requirements for software developed for medical purposes (e.g. medical-use software/software medical devices).

This medical-use software regulations training course is ideal for software developers, quality managers, manufacturing personnel, contractors, and SaMD personnel who design, supply, sponsor, maintain and/or monitor the safety of medical-use software products.

Regulations for medical-purpose software (e.g. software medical devices)

This course is recommended for anyone involved in the supply, maintenance and/or use of medical-purpose software (safety monitoring of medical-device software).

  • This online course introduces learners to regulatory requirements and harmonisation efforts for medical-purpose software.
  • Learners will gain an understanding of the compliance responsibilities of managers, manufacturers, employees, contractors and SaMD suppliers.

The course also explores recent trends in the SaMD and mHealth software app development industry – including why Regulators are changing regulations to ensure more rigorous product quality testing (and software safety monitoring) to protect patients and public healthcare outcomes.

Do I need to take this course?

  • Regulations for medical-use software mean manufacturers and sponsors have a legal obligation to meet quality, safety and efficacy standards.
  • Regulations state that GMP training of personnel and contractors/suppliers must be current, adequate, and ongoing (continual training, not merely an induction training course)

While this course is not intended to replace onsite training and product-specific GMP compliance Supervision, it is an excellent SaMD training resource to blend with your onsite training program(s).

The course is recommended for all responsible persons in pharmaceutical device manufacturing, including distribution personnel, software development teams and management teams tasked with designing, quality monitoring, and/or maintaining medical-use software products. This course may also be suitable for hospital purchasing professionals and individuals tasked with medical device quality management, medical software integration projects and software equipment maintenance. 

ICH guidelines GMP medical software regulations

The purpose of regulations and GMP compliance is to ensure patient safety and public health outcomes meet quality standards in terms of safety, accuracy, and reliably. It is important for patient safety to ensure all medical-purpose software programs work as intended.

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. 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.

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

What will you learn in the SaMD regulations compliance course for medical-purpose software

The medical software regulations training course covers safety, quality and efficacy regulations for medical-purpose software – available 24/7 upon ordering the training course – and is an ideal addition to in-house/onsite training.

  • The course references guidelines from leading authorities – including the FDA, TGA, EMA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • It helps 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

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.

This course including examples of GMP regulations for medical software being manufactured and/or sold in Europe (EMA), the UK (MHRA), the United States (FDA), and Australia (TGA).

What you’ll learn in the SaMD regulations compliance training course:

  • Medical-use software types and SaMD classifications according to IMDRF publications
  • Which software products and apps used in medicine are considered “medical devices” and subject to GMP regulations and other stringent quality controls
  • SaMD regulations including SaMD guidelines from the IMDRF and different countries including Australia, America, Europe and the UK
  • Differences between SaMD, software embedded in a medical device, and software used for health-improvement purposes (such as FitBits)
  • Classifications of medical-use software used for diagnostic purposes, remote condition monitoring, and/or clinical-treatment determination
  • The importance of ensuring a robust Quality Management System (QMS) using risk-management principles
  • The specific regulations and legal responsibilities that apply to manufacturers
    of SaMD products
  • Quality Risk Management
  • Software risks including cybersecurity

Who should take this SaMD regulations course?

The medical-use software regulatory compliance training module is suitable for:

New and long-term employees needing GMP regulations compliance training

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

This online GMP compliance training course is ideal for anyone working in the medical-use software sector. It is a particularly useful education 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).

GMP training: SaMD regulations compliance- Refresher Course

This Certificate GMP Course (available online) also makes an excellent induction OR refresher course for regulatory compliance for software product personnel, when combined with onsite training and product-specific training. Education purposes only.

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).