Clinical trial on Medical Device: complete development
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The document provides an overview of clinical trials for medical devices. It discusses definitions of medical devices according to FDA and Indian regulations, and classification of devices into classes based on risk level. The key phases of medical device clinical trials are pilot/feasibility studies and pivotal/confirmatory studies. Other topics covered include premarket notification (510k), investigational device exemption (IDE), premarket approval (PMA), differences between device and drug trials, and the global and Indian medical device markets.
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The classification is determined based on several factors, including whether the device is invasive or not, the duration of contact with the body, the body site it contacts, its functionality, and whether it is active or not. Non-invasive devices that only contact intact skin are usually Class A or B, while surgically invasive devices or those that administer drugs are higher classes C and D. Active devices that deliver energy to the body are also higher classes B, C or D depending on the level of risk.
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WHO Library Cataloguing-in-Publication Data
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standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
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Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
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Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
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Premarket Notification The 510(k) Process
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This document discusses medical device regulation and classification. It begins by defining medical devices and the purpose of regulation. Devices are classified by invasiveness, duration of use, and anatomical site into Class I, II, and III. Class I devices have the lowest risk, while Class III devices like pacemakers have higher risks. Marketing approval processes vary by class, from general controls for Class I, to 510(k) notifications for Class II that demonstrate substantial equivalence, to stringent Pre-Market Approval (PMA) required for new Class III devices which requires clinical trial data. The document also covers international standards, design control, risk management including failure mode and effect analysis, and risk control methods.
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Find more on: http://kobridgeconsulting.com/?p=767
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The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
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Classification of Medical Devices in Pakistan
Medical devices are classified into four classes - A, B, C, and D - based on the level of risk they pose. Class A devices pose the lowest risk while Class D devices pose the highest risk.
The classification is determined based on several factors, including whether the device is invasive or not, the duration of contact with the body, the body site it contacts, its functionality, and whether it is active or not. Non-invasive devices that only contact intact skin are usually Class A or B, while surgically invasive devices or those that administer drugs are higher classes C and D. Active devices that deliver energy to the body are also higher classes B, C or D depending on the level of risk.
Medical Device Regulations Global Overview And Guiding Principles
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
Risk Based Classification of Medical Devices and grouping
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
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The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
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India's medical device market is growing rapidly due to factors such as population growth, an aging population, rising chronic diseases, and increasing healthcare infrastructure and insurance penetration. The market was estimated at $3.9 billion in 2015 and is projected to reach $8.16 billion by 2020, driven primarily by growth in diagnostic imaging equipment. The government is taking several initiatives to promote the medical devices sector in India through policies supporting manufacturing, innovation, and quality standards.
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regulatory aspects of medical devices in USA
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Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
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Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...
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Avoca Presentation to Medical Devices Conferences
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The Australian regulatory framework for medical devices already captures cybersecurity. Manufacturers have been considering security in their design, and the Therapeutic Goods Administration (TGA) has been assessing and regulating the security of medical devices through the Essential Principles. However, the number of networked devices is growing, the risk profile is changing, and public awareness of cybersecurity as a risk is increasing.
This changing landscape has created new challenges for regulators of medical devices, including poor or unclear standardisation, sharing information, publication of vulnerabilities and exploits by users and security researchers, and poor transparency of expectations between stakeholders.
TGA is currently undertaking multiple projects to improve the regulation of medical device cybersecurity in Australia. These include, building on the existing capabilities to assess and measure medical device security, consulting with industry and other stakeholders on their challenges and expectations, and working to improve standardisation.
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
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EU MDR-compliant clinical documentation (English, Czech):
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The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
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What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
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Gain More Insight: https://bit.ly/3wWI0do
Get Sample Report: https://bit.ly/3ltFdo6
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An Italian medical device manufacturer wanted to conduct a post-market clinical trial abroad to obtain marketing data quickly. A contract research organization proposed conducting the randomized controlled trial at an investigational site in an extra-EU country to maximize resources and expedite the 6-7 month timeline for analyzed data. The CRO planned to translate and adapt the study documents to local requirements, monitor the site, obtain ethics approval, manage products on site, and analyze data remotely according to good clinical practice to meet the client's goals in a cost-effective manner.
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
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Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
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Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
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Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
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9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
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12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
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Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
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Clinical trial on Medical Device: complete development
- 1. Case 1: Clinical trial on Medical Device: complete development • Post-market Randomized Clinical Trial on Medical Device Copyright © 2013 Zeta Research S.r.l. 1
- 2. Case 1 Client: Italian Class I and II MD producer with international business network Client’s aims: Product’s evaluation concerning both clinical efficay (in traumatology) and commercial competitivity. Specific advanced requirements: RCT vs major pharma competitor Time and costs optimization Rigorous and transaprent data collected Compliance at Good Clinical Practice Copyright © 2013 Zeta Research S.r.l. 2
- 3. Case 1 Proposed solution: • Scientific planning of the trial, starting from scientific literature and producer’s technical and clinical data • Aims and endpoint definition • Sample caculation • Inclusion and exclusion criteria definition • Study design: • Randomized • Three treatment arms; MD’s comparators: 1. pharma major competitor 2. natural medicine major competitor • • eCRF drafting and programming for electronic data collection Remote data management Copyright © 2013 Zeta Research S.r.l. 3
- 4. Sviluppo completo di studio clinico su Medical DeviceCaso 1 Methods and tools • Scientific literature review on the major database (PubMed, Scopus etc) • Ethic documentations and approval management by an IEC. • Ad hoc eCRF drafting • Principal Investigator and site selection • Web-based data collection • IWRS for randomization and unblinding • Site monitoring • In house data analisys and reporting • GCP conformity Copyright © 2013 Zeta Research S.r.l. 4
- 5. Case 1 Client’s satisfied aims: • Data optimization and efficiency according to endpoints • Clear reporting • Rigorous and transparent data and resources optimization • Usefull data for clinical and market product’s positioning Copyright © 2013 Zeta Research S.r.l. 5