Software as a Medical Device: SaMD Regulations

Software as a Medical Device: SaMD Regulations

USD $60.00

Course duration: Allow from 2 to 4 hours to complete this course.

Description

SaMD regulations: Software as a Medical Device Regulations Training Course

Software as a Medical Device Regulations Training Course

Are your software developers, medical software suppliers, and end-users compliant with current SaMD regulations?

This Software as a Medical Device (SaMD) regulations training course covers GMP compliance requirements for software being developed for medical purposes, such as:

  • medical-use software that operates independently of other equipment
  • software used in conjunction with, but separate to, other medical devices
  • software/apps with complementary medical functions (example: radiotherapy guides that assist with drug delivery targets/treatment planning, but which do not rely on the delivery equipment and which operate separately)
  • software with diagnostic assistance functionality and/or dose management capacity

Who should complete the SaMD regulations training course covering requirements Software as a Medical Device (SaMD)?

Who should take this SaMD regulations course?

This Software as a Medical Device (SaMD) regulations training course is suitable for individuals who work with software product development and medical software products intended for use in healthcare settings and hospitals delivering medical care. It is useful for medical app/software designers, end-users, medical device software inventors and SaMD Quality Management personnel.

This GMP Certificate online course covering regulations that apply to Software as a Medical Device (SaMD) is available immediately upon ordering your course. Once you complete your online course purchase, then search your email folders for login information.

Your course will be available to you for 12 months from the date of purchase.


The SaMD regulations compliance training course will generally be suitable for individuals who have a role in developing, manufacturing, supplying, qualifying/validating, using and/or maintaining software products designed for use in medical settings.


These products (medical-purpose software) include all software products that have stand-alone medical capacity/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 (dosing regimes and treatment efficacy tracking).

FDA_TGA_MHRA_EMA_regulations-SaMD-whatisSaMD-medicaldevicesoftware

GMP regulations and requirements for Software classified as a Medical Device (SaMD).

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).

SaMD regulation compliance topics:

  • Different types of software and software classifications for medical-use software
  • 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 regulatory compliance by the IMDRF
  • GMP regulations for medical-purpose software
  • Quality control measures to reduce risks including user error, data integrity issues, coding errors
  • 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

Course Duration (Average course completion time frames):  Completion timeframes for this online SaMD regulations compliance training course will generally range from 2 hours to 4 hours in total, including the online Final Assessment regarding SaMD regulations compliance.

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

Of the key leanings you’ll gain by completing this Certificate GMP Course overviewing SaMD Regulations, you’ll gain clarity in relation to:
  • Different types of software and software classifications for medical-use software
  • Embedded vs independently-operating medical-use software
  • Which software products are classified as SaMD
  • SaMD regulations/GMP regulations compliance requirements for medical-use software
  • Recordkeeping and safety monitoring requirements for Software as a Medical Device (SamD) products

This medical-use software (SaMD) regulations training course is ideal for medical software designers, medical device developers, quality managers/quality assurance personnel, product quality testing personnel, suppliers, manufacturing personnel, contractors, and other pharmaceutical/medical device industry personnel who design, supply, sponsor, maintain and/or monitor the safety of medical-use software products (including end-users/healthcare workers of nonembedded medical device software).

SaMD-softwaremedicaldevice-FDA-TGA-EMA MHRA regulations for medical software

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

This course is recommended for anyone involved in the design, maintenance, supply or use of medical-purpose software.

Topic: Design criteria and safety monitoring of medical-device software (SaMD) products and GMP regulations

  • This online course introduces learners to regulatory requirements and harmonisation efforts for medical-purpose software including examples from the FDA, TGA, EMA, MHRA
  • Learners will gain an understanding of the regulatory 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 SaMD -software as a medical device

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 reliability.


It is important for patient safety to ensure all medical-purpose software programs work as intended.


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

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 training course

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

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 SaMD regulations compliance (orientation training) course references guidelines from leading authorities
  • Thes include 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).

This SaMD regulations compliance training course includes a variety of interesting topics related to software used in medical settings.

Examples include:

  • 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 SaMD GMP Regulations 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).

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.

  • 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).