Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Guidelines and Strategies for Safe Computer Charting01:18

Guidelines and Strategies for Safe Computer Charting

863
The guidelines and strategies provided by the American Nurses Association (ANA) and the Canadian Nurses Association (CNA) offer essential principles for ensuring safe and secure computer charting systems in healthcare settings. Let's break down each recommendation:
Maintain Confidentiality and Security:
863
Key Techniques in Microbiology01:29

Key Techniques in Microbiology

353
Aseptic techniques prevent contamination, ensure experimental accuracy, and protect researchers and microbial cultures. These techniques are essential in clinical, industrial, and research settings where sterility is required.Maintaining Sterility in Laboratory PracticesScientists maintain sterility by sterilizing tools with heat or chemicals, disinfecting work surfaces, and handling cultures in controlled environments. Working near an open flame or within a laminar flow hood reduces the risk...
353
Issues And Trends In Healthcare Delivery System01:29

Issues And Trends In Healthcare Delivery System

5.8K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.8K
Nursing Process for Patient and Caregiver Teaching III: Evaluation and Documentation01:20

Nursing Process for Patient and Caregiver Teaching III: Evaluation and Documentation

1.8K
Evaluation of the teaching process enables the nurse to determine if the patient's learning needs were met and if training was effective. If the expected outcomes are not met, the care plan is revised, and additional education or reinforcement is provided. Nurses can ask questions after the session or obtain feedback to assess the patient's understanding of the topic.
Nurses can use several methods to evaluate patient outcomes. For example, oral questions can assess cognitive learning,...
1.8K
Nursing Process for Patient and Caregiver Teaching I: Assessment and Diagnosis01:24

Nursing Process for Patient and Caregiver Teaching I: Assessment and Diagnosis

1.6K
The nursing process provides a clinical decision-making framework for patients and families to establish and implement a personalized care plan. Since part of the nurse's duties is to teach patients, the steps of the nursing process are the most effective way to approach instruction. The nursing process and the teaching-learning process are inextricably linked.
It is critical to determine the patient's learning needs during the assessment. Determination of learning needs compounds data...
1.6K
Asepsis01:28

Asepsis

2.3K
The condition of being free from disease-causing living pathogens is asepsis. Aseptic techniques include a set of standard practices to achieve asepsis. An example is the regular environmental cleaning of all parts of the healthcare facility and hand hygiene at home before preparing or eating food. Medical and surgical asepsis in healthcare practice protects patients from harmful pathogens, minimizes the risk of contamination of susceptible sites, and reduces the risk of infection transmission.
2.3K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Integrating Radiomics and Machine Learning to Improve Fluorescence Image Segmentation in in vitro models.

Studies in health technology and informatics·2026
Same author

Data Warehouse to Support Clinical Trials in Dentistry.

Studies in health technology and informatics·2026
Same author

The challenges of national health data ecosystems in feeding the European health data space: the Italian example.

Frontiers in medicine·2025
Same author

Changes in attitudes towards prenatal diagnosis for haemoglobinopathies: a 40-year retrospective observational study in Northern Italy.

BMJ open·2025
Same author

Impact of the auscultation area on heart sound waveforms for the estimation of Cardiac Time Intervals.

Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference·2025
Same author

Pilot study on the separability of the native heart sounds and device support noise in patients implanted with left ventricular assist devices.

Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference·2025
Same journal

The Essential Components and Critical Conditions for Success in a Learning Health System in Oncology.

Studies in health technology and informatics·2026
Same journal

Use of Artificial Intelligence in Screening for Adolescent Idiopathic Scoliosis: A Scoping Review.

Studies in health technology and informatics·2026
Same journal

Movement Related Biomechanics in Adolescent Idiopathic Scoliosis: A Review of Reviews.

Studies in health technology and informatics·2026
Same journal

The Impact of Surgical Correction of Adolescent Idiopathic Scoliosis Using Posterior Spinal Fusion on Selected Radiological Parameters and Respiratory Function.

Studies in health technology and informatics·2026
Same journal

Acute Effect of Physio-logic® Exercises on Muscle Tone and Stiffness in Adolescent Idiopathic Scoliosis Patients: A Preliminary Study.

Studies in health technology and informatics·2026
Same journal

Effects of Integrated Music and Occupational Therapy on Motor and Autonomic Function in Children with Neurogenic Scoliosis.

Studies in health technology and informatics·2026
See all related articles

Related Experiment Video

Updated: Aug 29, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

3.6K

Key Aspects to Teach Medical Device Software Certification.

Noemi Giordano1, Samanta Rosati1, Marco Knaflitz1

  • 1Department of Electronics and Telecommunications, Politecnico di Torino, Torino, Italy.

Studies in Health Technology and Informatics
|September 8, 2022
PubMed
Summary
This summary is machine-generated.

Medical Device Software (MDS) certification under EU regulations requires proving safety and effectiveness. A course syllabus must include risk analysis and systematic reviews with meta-analysis to demonstrate MDS performance and compliance.

Keywords:
MDS certificationMedical device softwaremeta-analysisrisk assessmentsoftware as medical device

More Related Videos

Medical-grade Sterilizable Target for Fluid-immersed Fetoscope Optical Distortion Calibration
07:03

Medical-grade Sterilizable Target for Fluid-immersed Fetoscope Optical Distortion Calibration

Published on: February 23, 2017

7.8K
Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
10:43

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

Published on: June 27, 2014

20.0K

Related Experiment Videos

Last Updated: Aug 29, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

3.6K
Medical-grade Sterilizable Target for Fluid-immersed Fetoscope Optical Distortion Calibration
07:03

Medical-grade Sterilizable Target for Fluid-immersed Fetoscope Optical Distortion Calibration

Published on: February 23, 2017

7.8K
Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
10:43

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

Published on: June 27, 2014

20.0K

Area of Science:

  • Medical device regulation
  • Software engineering
  • Regulatory compliance

Background:

  • EU Medical Device Regulation 2017/745 mandates rigorous certification for Medical Device Software (MDS).
  • Ensuring the safety and effectiveness of MDS is paramount for patient well-being and regulatory approval.
  • Existing training syllabi may lack comprehensive tools for addressing these critical aspects.

Purpose of the Study:

  • To outline essential components for a Medical Device Software development course syllabus.
  • To detail methodologies for demonstrating MDS safety and effectiveness.
  • To align MDS development training with EU Medical Device Regulation 2017/745 requirements.

Main Methods:

  • Implementing a structured four-step risk analysis procedure for safety assurance.
  • Utilizing systematic literature reviews to gather evidence on MDS performance.
  • Conducting meta-analysis to quantitatively compare MDS effectiveness against similar tools.

Main Results:

  • A defined four-step risk analysis process is proposed for robust safety assessment.
  • Systematic review and meta-analysis provide a quantitative framework for demonstrating MDS effectiveness.
  • The proposed syllabus components directly address the certification demands of the EU MDR 2017/745.

Conclusions:

  • A comprehensive MDS development course must integrate risk management and evidence-based effectiveness demonstration.
  • Adherence to structured methodologies like risk analysis and meta-analysis is crucial for regulatory compliance.
  • Training programs should equip developers with the necessary tools to meet stringent EU medical device software standards.