ISO 13485 is an international quality management standard for medical device companies. It incorporates the process approach of ISO 9001 and specifies additional requirements for design controls, risk management, and regulatory compliance. Certification to ISO 13485 demonstrates that a company's quality management system meets regulatory requirements for medical devices in Europe and many other countries. The document outlines the benefits of ISO 13485 certification such as improved processes, regulatory compliance, and competitive advantage. It also describes the certification process and the services provided by Lakshy Management Consultant Pvt. Ltd. to help clients implement ISO 13485 and achieve certification.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
siddhartha consultancy services
www.scsuniversal.com
HR Consulting
Competency Mapping
Assessment Center
Mentoring
Performance Evaluation and Linking
with Reward Systems
Designing HR Processes
HR Outsourcing
Training Need Analysis
Training Evaluation
Psychometric Testing
Personality Profiling
Individual, Team and Organizational Tests
Organizational Survey
Recruitment for National and Overseas
Skills and Competency based selection
Competency Assessment for short listed candidates to fulfill the exact needs of jobs
Training Programmes at SCS
Managerial Skills
Communication Skills
Presentation Skills
Team Building
Leadership
Emotional intelligence
Time and Task Management
Creativity and Problem Solving
Analytical Thinking and Decision Making
Soft skill training for management trainees
Stress Management
HR for Line Managers
Interviewing Skills
Mentoring and Coaching
Counseling
Competency Mapping
Psychometric Testing
ISO 9001 /- Quality Management System
ISO 14001 - /Environment Management System
OHSAS 18001 - /Occupational Health & Safety
ISO 22000 / HACCP / BRC - /Food Safety Management
ISO 27001 - /Information security Management System
Software Management , Risk Assessment/ Design Management, Audit Services
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
siddhartha consultancy services
www.scsuniversal.com
HR Consulting
Competency Mapping
Assessment Center
Mentoring
Performance Evaluation and Linking
with Reward Systems
Designing HR Processes
HR Outsourcing
Training Need Analysis
Training Evaluation
Psychometric Testing
Personality Profiling
Individual, Team and Organizational Tests
Organizational Survey
Recruitment for National and Overseas
Skills and Competency based selection
Competency Assessment for short listed candidates to fulfill the exact needs of jobs
Training Programmes at SCS
Managerial Skills
Communication Skills
Presentation Skills
Team Building
Leadership
Emotional intelligence
Time and Task Management
Creativity and Problem Solving
Analytical Thinking and Decision Making
Soft skill training for management trainees
Stress Management
HR for Line Managers
Interviewing Skills
Mentoring and Coaching
Counseling
Competency Mapping
Psychometric Testing
ISO 9001 /- Quality Management System
ISO 14001 - /Environment Management System
OHSAS 18001 - /Occupational Health & Safety
ISO 22000 / HACCP / BRC - /Food Safety Management
ISO 27001 - /Information security Management System
Software Management , Risk Assessment/ Design Management, Audit Services
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
The primary objective of ISO 13485 certification is to standardize regulatory requirements for quality management systems. URS provide ISO 13485 certification in all India.
How to Prepare Your Organization for the Transition to ISO 13485:2016Greenlight Guru
The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late February 2016.
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here.
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
In this presentation, you'll learn:
-What your organization needs to be doing to prepare for the transition to ISO 13485:2016
-Why the transition presents an opportunity for your organization to implement better processes
-An overview of the specific changes coming with ISO 13485:2016
-The actions you should be taking now and how to plan for the implementation of the standard
Access full presentation here: https://www.greenlight.guru/webinar/iso-13485-2016-transition-planning
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
The good thing about being ISO 13485 standardized is that it offers a global valid guarantee over your product and your company can attract a lot of contracts. URS is offering value added assessment and certification services in all India.
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
The primary objective of ISO 13485 certification is to standardize regulatory requirements for quality management systems. URS provide ISO 13485 certification in all India.
How to Prepare Your Organization for the Transition to ISO 13485:2016Greenlight Guru
The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late February 2016.
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here.
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
In this presentation, you'll learn:
-What your organization needs to be doing to prepare for the transition to ISO 13485:2016
-Why the transition presents an opportunity for your organization to implement better processes
-An overview of the specific changes coming with ISO 13485:2016
-The actions you should be taking now and how to plan for the implementation of the standard
Access full presentation here: https://www.greenlight.guru/webinar/iso-13485-2016-transition-planning
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
The good thing about being ISO 13485 standardized is that it offers a global valid guarantee over your product and your company can attract a lot of contracts. URS is offering value added assessment and certification services in all India.
ISO 9001: 2008 Quality Management System (QMS) is a Process Standard & not Product Standard
ISO QMS International Standard ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade
This PPT is for creating basic awareness on Standard for Implementation, understanding the importance & Benefits of Standard to improve Business & journey towards Excellence
The ISO 13485:2016 standard governs quality management for medical devices and related services. It’s published by the International Organization for Standardization (ISO).
Get a free ISO 13485 quote from NQA today here: https://www.nqa.com/en-gb/certification/standards/iso-13485
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
ISO 13485 Certification Everything You Need to Know.pdfOFFICE
ISO 13485 is a globally accepted standard designed to help medical device manufacturers maintain and continuously improve their quality management systems. It outlines the requirements for a comprehensive quality management system, covering every aspect from product development to manufacturing and post-market surveillance. This standard ensures that medical devices meet regulatory requirements and maintain the highest level of safety and efficacy.
ISO 13485 Certification: Benefits for Your Medical Device CompanyOFFICE
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Medical device QMS. A medical device is a product, such as an instrument, machine, implant or in vitro reagent that is intended for use in the diagnosis, prevention and treatment of diseases, rehabilitation of illness and disease or other medical conditions. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
SIS CERTIFICATIONS Arunendra Dvivedi +91 8860610495 or email us : support@siscertifications.com. International Organization for Standardization ISO. www.siscertifications.com, Overview of ISO 9001, ISO 14001, 27001, ISO 45001, ISO 41001 and CMMI certifications. ISO 27001 and ISO 45001.
Regulatory 101 for Medical Device Start UpsEMMAIntl
In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
The current ISO 13485 edition was published on 1 March 2016.
These standards are guidelines on how to document the processes in specific industries. The goal is consistency and a set of complete, easy to follow instructions. ISO 9000 is a set of five guideline standards that define the requirements for an effective quality management system.
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This ISO 13486 awareness PPT training presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge of ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips for handling an audit session
ISO/TS 29001:2010 defines the quality management system requirements for the design, development, production, installation and service of products for the petroleum, petrochemical and natural gas industries.
Risk management is an increasingly important business driver and stakeholders have become much more concerned about risk. Risk may be a driver of strategic decisions, it may be a cause of uncertainty in the organization or it may simply be embedded in the activities of the organization.
The ISO 22000:2005 FSMS is designed to enable organizations to control food safety hazards along the food chain in order to ensure that food is safe at the time of consumption.
ISO 17020, entitled "General Criteria for the Operation of Various Types of Bodies Performing Inspection", is an internationally recognized standard for the competence of inspection bodies. ISO 17020 should not be confused with ISO 9001, which is specific to quality management systems. ISO 9001 does not require evaluation of the technical competence of an inspection body and it should not be regarded as an 'acceptable' alternative to ISO 17020.
"ISO 14001 environmental management standards exist to help organizations minimize how their operations
negatively affect the environment. The major objective of the ISO 14000 series of norms is "to promote more
effective and efficient environmental management in organizations and to provide useful and usable tools - ones
that are cost effective, system-based, and flexible and reflect the best organizational practices available for
gathering, interpreting and communicating environmentally relevant information"".
ISO 27001 is applicable to any organization where the
misuse, corruption, or loss of its business or customer
information could result in financial, continuity, or legal
implications. The information may be printed or written
on paper, stored electronically, transmitted by post or
email, shown on films, or spoken in conversation,
whatever form the information takes, or means by which
it is shared or stored.
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The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
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.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
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
www.agostodourado.com
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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1. Lakshy Management Consultant Pvt. Ltd.
White Paper on ISO 13485 QMS – Quality Management System for Medical Devices
Lakshy Management Consultant Pvt. Ltd.:- 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400614, India – R01-310809
I 24 Hours Customer Care: +91 9821780035 I Phone +91 32995241 I Web: www.lakshy.com I Email: info@lakshy.com I
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W h a t i s I S O 1 3 4 8 5 : 2 0 0 3 ?
You can’t buy trust. BUILD IT through ISO 13485.
Demonstrate your ability to supply medical devices through Quality Management System for Medical Devices - ISO 13485
ISO 13485 is the quality management system standard for medical devices. This standard applies the ISO 9001:2008 process
approach to quality, and replaces ISO 13485:1996 and ISO 13488:1996.
ISO 13485:2003 provides an effective base model for compliance with the EU CE marking Medical Devices Directives
requirements. ISO 13485:2003 is also considered to be fully compatible with the FDA QSR.
ISO 13485 is an international standard, recognized throughout the world for establishing a business management system
specific to the medical device industry. ISO 13485 is applicable to organizations that manufacture private label medical devices,
in vitro diagnostic medical devices, and medical components.
The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. Some of the additional requirements
to ISO 9001 requirements relate to
• Design controls,
• Risk management,
• Environmental controls,
• Special processes (e.g. Software validation),
• Traceability, record retention, and
• Regulatory actions (such as vigilance),
ISO 13485: 2003 has been harmonised against the medical device directives.
• Medical Devices Directive
• Active Implantable Médical Devises Directive,
• In Vitro Diagnostic Directive
This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives
that require a quality management system.
Formal certification of quality management system, specifically for medical devices, to ISO 13485:2003 proves advantageous,
for medical companies which export their products to the global market.
• In the European Union, the fulfillment of EU Directives (e.g. Active Implantable Medical Devices Directive, Medical
Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices.
• Canada requires that medical device manufacturers marketing their products in Canada must have a quality system
certified to ISO 13485 by an accredited certification body.
2. Lakshy Management Consultant Pvt. Ltd.
White Paper on ISO 13485 QMS – Quality Management System for Medical Devices
Lakshy Management Consultant Pvt. Ltd.:- 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400614, India – R01-310809
I 24 Hours Customer Care: +91 9821780035 I Phone +91 32995241 I Web: www.lakshy.com I Email: info@lakshy.com I
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ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management
systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.
Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place
is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes,
namely the processes specific to the safe design, manufacture and distribution of medical devices.
13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and—
preeminently—various global regulators. While being certified to 13485 does not fulfill the requirements of either the FDA or
foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality
System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore,
13485 certification serves to create a management system that can be thought of as a framework on which to build compliance
to various regulatory and customer requirements.
13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle,
from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971:
2001, Application of Risk Management for Medical Devices. While 13485 states that a manufacturer’s management team is
charged with the management of device-related risks and the development of risk management plans, 14971 defines a list of
steps to be taken by management in order to fulfill risk-related requirements. While it is not mandatory that a manufacturer be
14971 certified in order to attain 13485 certification, being certified to the former standard can ease the attainment of
certification to the latter.
3. Lakshy Management Consultant Pvt. Ltd.
White Paper on ISO 13485 QMS – Quality Management System for Medical Devices
Lakshy Management Consultant Pvt. Ltd.:- 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400614, India – R01-310809
I 24 Hours Customer Care: +91 9821780035 I Phone +91 32995241 I Web: www.lakshy.com I Email: info@lakshy.com I
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B e n e f i t s o f I S O 1 3 4 8 5 C e r t i f i c a t i o n
ISO 13485 implementation improves / leads to :-
• POLICIES & OBJECTIVES set by 'top management'
• Conformance to Legal and Regulatory Requirements
• Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design
and manufacturing regulatory requirements
• Controlled consistency of manufactured products
• Managed productivity and efficiency, controlling costs
• Competitive advantage and increased marketing and sales opportunities.
• Improved customer perception of the organization’s image, culture and performance.
• improved internal and external Communications
• greater understanding of the organization's processes
• clear responsibilities and authorities agreed for all staff
• improved use of time and resources
• reduced wastage
• greater consistency and traceability of products and services
• Customer Confidence, Satisfaction and TRUST
• Level of Assurance in Organisational QUALITY
• Organisational PROFITABILITY
• Ability to Differentiate Organisation for Competitive Advantage
• Organisational Credibility & Reputation
4. Lakshy Management Consultant Pvt. Ltd.
White Paper on ISO 13485 QMS – Quality Management System for Medical Devices
Lakshy Management Consultant Pvt. Ltd.:- 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400614, India – R01-310809
I 24 Hours Customer Care: +91 9821780035 I Phone +91 32995241 I Web: www.lakshy.com I Email: info@lakshy.com I
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T h e C e r t i f i c a t i o n P r o c e s s
It also is important to keep the target market in mind. For instance, if a medical device manufacturer
wants to sell in North America, it should seek certification through a registrar accredited by a North
American accreditation body to ensure they will meet country-specific or customer requirements.
If a consultant is required, the organization needs to be sure that the prospect has expertise in 13485,
and requesting referrals from an accredited registrar also can aid in finding the right match. It is
important that the consultant understands the organization’s business, that the consultant has dealt
with organizations of a similar size before and has had experience with similar product lines.
Also, an organization should be wary of consultants that endeavor to radically change a management
system that is already performing well. Steve Upton, medical device business unit manager for NQA, states, “The consultant
should come in and align their knowledge with your requirements and the customer requirements, and that will work time after
time.”
The steps to attaining 13485 certification are similar to those of 9001, with some type of off-site document review followed by a
preassessment and then assessment. After certification, an organization will be subject to on-going surveillance by its
certification body. The duration of the assessment is contingent on an organization’s scope—its size, number of personnel, and
type and complexity of products manufactured. Taking these elements into consideration, an organization can expect an
assessment to last anywhere from a couple of days to more than a month.
The frequency of surveillance assessments will be determined by an organization’s scope as well as its performance, though
they will usually be conducted annually or semi- annually. However, organizations should expect a complete reassessment
three years after initial certification. A surveillance assessment takes into account concerns such as the fulfillment of
management responsibilities, the execution of internal audits and how an organization is performing in relation to the state of the
industry and customer expectations.
W h o C a n G o F o r I S O 1 3 4 8 5 C e r t i f i c a t i o n ?
• Companies that design, manufacture, distribute, install and service medical devices for the European and World
markets.
• Companies who manufacture OEM products which are sold under other company names.
• Companies who design and/or manufacture medical device components or raw materials for the medical device market.
• Companies selling, installing or servicing medical devices.
• Consultants providing design services to the medical device market.
• Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc.
An ISO 13485
management system
can be thought of as a
framework on which to
build compliance to
various regulatory and
customer requirements.
Source: Fresenius AG
5. Lakshy Management Consultant Pvt. Ltd.
White Paper on ISO 13485 QMS – Quality Management System for Medical Devices
Lakshy Management Consultant Pvt. Ltd.:- 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400614, India – R01-310809
I 24 Hours Customer Care: +91 9821780035 I Phone +91 32995241 I Web: www.lakshy.com I Email: info@lakshy.com I
Page 5 U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
W h a t w e d o
Lakshy Management Consultant Pvt. Ltd. provides proven, proprietary implementation and training support to assure that your
organization meets applicable ISO 13485 requirements promptly and effectively. A certified ISO 13485 Quality Management
System will
• Assure you meet all customer quality requirements
• Improve your organization's competitiveness
• Eliminate waste
• Reduce risk
• Control process variation
Lakshy Management Consultant Pvt. Ltd. ISO 13485 QMS Implementation Support is loaded with advantages for your
organization.
We offer choices... you decide just how much support you need.
• Basic Support provides a process-based, documented, implemented, audited Quality Management System
(QMS), acknowledging all ISO 13485 quality requirements, ready for certification.
• Full Support provides everything in Basic Support, plus we will train and mentor an Internal Quality Audit team for
your organization.
Lakshy Management Consultant Pvt. Ltd. will witness your certification audit, if you choose. Everything we provide meets one or
more ISO 13485 requirements, including
• a quality manual unique to your organization, acknowledging all ISO 13485 requirements (no "gap assessment"
required)
• documentation and implementation support for your value
• added quality management system
• development of a simple, effective document and record control system
• training of an Internal Quality Audit Team, if you choose
• a mentored, full system audit of the new quality management system (no registrar "preliminary assessment"
required)
• corrective/preventive action support from the full system audit
• recommendation for an economical, effective registrar, if you choose
• our witness of your registration audit, if you choose
We take the time necessary to custom fit all applicable ISO 13485 requirements to your organization. No "consultant" is as
willing and able as Lakshy Management Consultant Pvt. Ltd. to take the time to build a QMS to both reduce your costs and
"pass the audit," guaranteed!
At Lakshy Management Consultant Pvt. Ltd., we always offer No-Nonsense Pricing, all expenses included. We welcome
comparison! Lakshy Management Consultant Pvt. Ltd. proven, proprietary implementation and training methods assure your
organization meets all ISO 13485 requirements in minimal time and at lowest cost.
Your organization is very busy... everyone wears more than one hat. Time to implement a quality management system is often
limited. We take less time to get you certified. Quality system implementation is a "team sport..." however, if your organization
does not have the time, we can deliver a turn-key system, guaranteed to get you certified.
6. Lakshy Management Consultant Pvt. Ltd.
White Paper on ISO 13485 QMS – Quality Management System for Medical Devices
Lakshy Management Consultant Pvt. Ltd.:- 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400614, India – R01-310809
I 24 Hours Customer Care: +91 9821780035 I Phone +91 32995241 I Web: www.lakshy.com I Email: info@lakshy.com I
Page 6 U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
Our methods never include one-size-fits-all, "cookie-cutter" approaches. ISO 13485 quality systems requires process
approaches, customer focus, and continual improvement. You cannot get that from a cookie cutter. Most importantly, our quality
management systems improve your bottom line. "Cookie cutter" approaches do not work, and only add cost.
When we leave, the quality management system is yours, not ours. We provide all the knowledge and experience your
organization needs to effectively manage and improve your certified QMS in the future. When we are finished, your organization
owns your ISO 13485 quality management system.
Lakshy Management Consultant Pvt. Ltd. is our association of experienced, creative, enthusiastic quality professionals
committed to building and improving quality systems while permanently reducing quality costs.
This is what we do... we would welcome the opportunity to work with you!
For more information & customized assistance, please send us an email at info@lakshy.com