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.
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.
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).