Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations.
In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Q1 Medical Devices Regulation - practical consequences for manufacturersErik Vollebregt
Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
Webinar: "The future of European Medical Device Regulations"pi
www.3-14.com
Presentation from our webinar on the 1st June 2016, concerning the future of the European Medical Device Regulations.
Following topics were discussed:
- Proposed MDR scope and definitions
- Economic operators and Person Responsible for regulatory compliance
- Classification and conformity assessment
- Notified Bodies
- Clinical evaluation/investigation
- Technical Documentation – NEW requirements
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations.
In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Q1 Medical Devices Regulation - practical consequences for manufacturersErik Vollebregt
Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
Webinar: "The future of European Medical Device Regulations"pi
www.3-14.com
Presentation from our webinar on the 1st June 2016, concerning the future of the European Medical Device Regulations.
Following topics were discussed:
- Proposed MDR scope and definitions
- Economic operators and Person Responsible for regulatory compliance
- Classification and conformity assessment
- Notified Bodies
- Clinical evaluation/investigation
- Technical Documentation – NEW requirements
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
OEMs and suppliers see promise in the ability of manufacturing and software to expand the use of custom implants in orthopaedics. Multiple companies are focused on the custom market. This session provides the surgeon perspective on these devices. What are the benefits? When should and shouldn't they be used? Will the market take off?
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
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
EU General Data Protection Regulation top 8 operational impacts in personal c...Erik Vollebregt
Presentation to the Personal Connected Health Alliance about the top 8 operational impacts of the EU General Data Protection Regulation on companies in the personal connected health field.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
This webinar goes over the major changes of the new ISO 13485:2016 standard, including the upgrade process. Program Manager Rick Burgess presented and responded to questions live on the webinar.
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
New medical device regulation: implications for medical device manufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn More: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
Whatsapp: +91 9884350006
New Medical Device Regulation Implications For Medical Device ManufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn more: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
Whatsapp: +91 9884350006
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.
Eu Regulatory & Quality Environment- Abhishek RavalAbhishekRaval16
Contains-
History, Geography, Political Equations, Type of Procedures, DE& ME, All Regulatory Procedures incl. PLCM, Pharmacovigilance, GMP Insights, Control of API, Supply Chain, Various Fees, Discussion on Pro's & Con's Of MAH vs CMO model business.
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
This presentation, created by Syed Faiz ul Hassan, explores the profound influence of media on public perception and behavior. It delves into the evolution of media from oral traditions to modern digital and social media platforms. Key topics include the role of media in information propagation, socialization, crisis awareness, globalization, and education. The presentation also examines media influence through agenda setting, propaganda, and manipulative techniques used by advertisers and marketers. Furthermore, it highlights the impact of surveillance enabled by media technologies on personal behavior and preferences. Through this comprehensive overview, the presentation aims to shed light on how media shapes collective consciousness and public opinion.
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.