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Article Index

The webinar library offers you a place to revisit webinars featuring regulatory and industry experts. 

If you are looking for a webinar that is not posted below, please feel free to contact us.

 

Stepping into an MDSAP audit

Webinar gmed notified body play

Stepping into the program when carrying already other regulatory certifications requires from medical device companies to understand not only the approach but the expectations set by the applicable regulations and the concept carried on by the program:

From the MDSAP auditing scope to the MDSAP grading system for non-conformities and the duration of the MDSAP audit , everything within the MDSAP format is thought to ensure consistency in introducing a harmonized approach meant to provide a global benefit both on short term goals and longer term goals by IMDRF regulators and benefit patient health and patient access.

LNE GMED ARROW Click here to watch the video.

 

CE Marking of Medical Devices: Elements to be provided during the Evaluation of the Technical Documentation

 

The webinar addresses the following main points:

Update /creation of the list of elements to be provided for the CE marking of a Medical Device in the context of:
• An Initial evaluation
• Evaluation of a change
• Evaluation of a renewal

LNE GMED ARROW Click here to watch the video.

IVD European Regulation: how QMS requirements interacts with ISO 13485:2016

 

Join LNE/G-MED and Dr. Julien Sénac for a discussion on the In Vitro Diagnostic (IVD) European Regulation: its impacts on the compliance with ISO 13485:2016. Dr. Sénac will talk about:

- The new requirements introduced by the European IVD Regulation with respect to the Quality Management System to the In Vitro Diagnostic (IVD) legal manufacturers

- The major changes of ISO 13485:2016

- How the requirements and changes for both the IVD regulation and ISO 13485:2016, interact and complement each other.

LNE GMED ARROW Click here to watch the video.

Medical Device Usability: Highlights of European Regulations and the Latest Standards

Each year, medical device incidents due to use/user errors caused mainly by poor user interface design are reported, some can lead to severe harm to the patients. What process is in place to limit these failures and are these avoidable?

This webinar discuss Usability Engineering Process, its link to Risk management and Quality management system and highlights European requirements:
- Usability
- Usability and European Regulations and Standards
- Overview of Usability Standards and the latest changes
- Usability and Medical Device QMS

LNE GMED ARROW Click here to watch the video.

Post-Market Surveillance requirements under the new European Medical Device Regulations

In the current Medical Device Directives, Post Market Surveillance is defined in Chapter I, Article 2, (40a), as the action requiring Medical Device Manufacturers to “proactively collect and review experience gained from their devices placed on the market.”

With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers. While a continuous evaluation and improvement of the process is at the very heart of this change, the Regulations introduces more incisive and prescriptive measures based on device risk level for both the MDR and IVDR.

LNE GMED ARROW Click here to watch the video.

Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives

The publication of ISO 13485:2016 in March last year reinforced the notion of control of supply chain for Medical Device manufacturers.

With a clear reinforcement of the risk-based approach in the entire ISO 13485:2016, it is no exception that the Purchasing section (7.4) includes new provisions to strengthen Supplier control.

Requirements are mostly written towards the medical devices legal manufacturer to control its suppliers, however it is critical that suppliers are also aware about them as they could also be ISO 13485 certified.

The updated standard gives more details about what companies shall consider in the process of evaluation, selection and monitoring of their suppliers. It not only amends the management of Supplier relationships, but also puts in perspective the whole process of supplier selection.

LNE GMED ARROW Click here to watch the video.

The Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR): Changes and Impacts

In this webinar, you will learn about the new Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR): Changes and Impacts for Medical Devices manufacturers. 

The final publication for both regulations is expected for no later than May 2017.

The manufacturers will phase out from the respective directives governing their currently approved medical devices through a transition period of three years and fully embrace the requirements of the MDR, which will take full effect in 2020.

The same is expected for In Vitro Diagnostic Medical Device Manufacturers with a transition period of 5 years, and the IVDR becoming enforceable by the end of 2022.

LNE GMED ARROW Click here to watch the video.

 

Notification of changes: How, what and when to communicate with your Notified Body?

In this webinar, you will learn about:

  • Definition of change notice (significant change, minor change etc.)
  • Common scenarios of change notices (relocation, extension within scope, design change, transition to new standard etc.)
  • Ideal timelines for communication of change notice to your Notified Body
  • FAQ

LNE GMED ARROW Click here to watch the video.

Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers

LNE/G-MED is exploring during this webinar the following points:

  • Initial audit planning
  • Common pitfalls
  • Quality Management System
  • Purchasing
  • Internal Audit
  • Product Realization
  • After Audit Conclusion

LNE GMED ARROW Click here to watch the video.

MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)

LNE/G-MED is exploring during this webinar the following points:

  • IMEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)
  • Clinical Equivalence
  • Technical Equivalence
  • Biological Equivalence
  • Assuming Equivalence
  • The new developments of MEDDEV 2.7.1 rev 4

LNE GMED ARROW Click here to watch the video.

Embedded Software in Medical Device: Common Regulatory and Quality pitfalls

LNE/G-MED will be exploring during this webinar the following points:

• Important definitions and Descriptions
• What is an embedded software medical device in Europe?
• How to classify an embedded software?
• Use of harmonized standard EN 62304
• Which conformity assessment route for the CE marking of my software?
• Regulation and regulators approach.

LNE GMED ARROW Click here to watch the video.

Clinical and Performance evidence requirements in the future EU IVD Regulation

In this webinar, you will learn about:

• Clinical Evaluation / Performance studies requirements in the IVDR
• Similarities in Performance requirements between the IVDD and IVDR
• Requirements for currently CE marked IVD products
• Scenarios of performance studies for different IVD products under the new IVDR

LNE GMED ARROW Click here to watch the video.

Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals

In this webinar, you will learn about:
• Impacts of critical suppliers on the Manufacturer’s Certification Process
• Definitions and approaches in auditing
• Evaluation approach of critical supplier
• Outsourcing and the role of the Legal Manufacturer

LNE GMED ARROW Click here to watch the video.

Evolution of ISO 13485:2016 and ISO 9001:2015 standards

In order to help you comprehend these changes, LNE/G-MED will be exploring during this webinar the following points:
• The structure of those new management system standards
• The main changes and evolutions introduced by the new versions for both ISO 9001 and 13485:
 - Scope and Definitions
 - Quality Management System Requirements
 - Resources Management
 - Product Realization, including Risk Management, Design Process, Purchasing…
 - Measurement, Analysis and Improvement
• Can a QMS be compliant with both ISO 9001:2015 and ISO 13485:2016 standards?

LNE GMED ARROW Click here to watch the video.

Medical Device Compliance during Merger and Acquisition and the role of Notified Bodies

In the last couple of years, the medical device industry has seen record numbers of mergers and acquisitions. Monir El Azzouzi, Quality and Regulatory Compliance Manager at Johnson & Johnson and our Legal and Regulatory Director at LNE/G-MED, Sarah Stec discuss Medical Device Compliance during Merger and Acquisition and the role of Notified Bodies during the transition:
• Due Diligence and review of the Notified Body
• The crash test phase of the Merger & Acquisition
• Merger & Acquisition Planning
• What Notified Bodies need to know
• QMS integration plans. 

LNE GMED ARROW Click here to watch the video.

Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics

LNE/G-MED North America’s webinar on the revisions of EU regulations & the reclassification of In Vitro Diagnostics discusses:

• The state of the EU regulations and the processes it entails
• The evolution of the EU IVDD.
• Possible classification changes and the corresponding pathway for CE Marking
• Potential impacts for IVD manufacturers. 

LNE GMED ARROW Click here to watch the video.

Reclassification of Medical Devices, upcoming revisions of EU regulations

Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. In this webinar, we will analyze the positions of the three main actors (EU Commission / Parliament / Council), focusing on the potential changes affecting the classification of MD and IVD devices, as well as:

• The state of the EU regulations and the processes it entails
• The evolution of the EU regulations
• Possible classification changes and the corresponding pathway for CE Marking
• Potential impacts for MD and IVD manufacturers

LNE GMED ARROW Click here to watch the video.

Recent EU Medical Device Regulatory Evolutions: Moving Forward

In June 2015, the EU Council published a set of revisions to the EU medical devices and IVD regulatory proposals. This webinar will cover the following topics:

• Reclassifications and regulatory scope expansions,
• Conformity assessment changes proposed in the documents, and
• What the next steps are in the process.

LNE GMED ARROW Click here to watch the video.

Medical Devices Containing Ancillary Medicinal Substances

Developing and marketing a medical device combined with a medicinal substance requires an acute understanding from the manufacturer of its obligations and the requirements involved with putting such a device on the EU market. In this webinar, you will learn about:

• The key definitions and clauses required to be fulfilled for the different directives
• The actors and different aspects of the submission
• Understanding the classification of device-drug combination products
• The procedure for evaluation of Quality, Safety and Usefulness of a medicinal substances ancillary to a medical device
• The guidance documents available

LNE GMED ARROW Click here to watch the video.

The IVD Directive and Borderline Products

Choosing the correct regulation can sometimes be challenging when a device can potentially be classified under more than one regulation. Products that fall into this category are commonly called “Borderline” products. Determining the correct regulatory path becomes crucial for them as it can lead to higher costs and a hazier market access path. In this webinar, we will discuss:

• The key definitions within the MDD and IVDD
• The clauses required to be fulfilled for IVD devices
• Scenarios for exclusion from the IVDD
• Specific examples of borderline IVD devices
• Guidance documents

LNE GMED ARROW Click here to watch the video.


 

Russia Medical Device Market Access and ISO 13485 certification for the ROW

Join LNE/G-MED and Alexey Stepanov, Regulatory and Quality Assurance Manager Russia and CIS at Sorin Group to have a clear view on the Russian medical device registration process, as well as how to leverage your current product submissions to make your Russian application less labor-intensive. Medical device manufacturers will learn about:

• The Russian medical device registration regulations,
• ISO 13485’s role in the Russian medical device registration regulations, and
• How a manufacturer with CE marking can re-use parts of their CE marking submission for their Russian medical device registration.
• If you’re a device manufacturer in Russia, the steps for CE marking.

LNE GMED ARROW Click here to watch the video.

Sampling of Medical Devices during Unannounced Audits

Systematic unannounced audit are now broadly implemented following the European Directives requirements and Recommendation 2013/473/EU. One of the provisions of the Recommendation relates to the sampling Notified Bodies could perform during their unannounced audits. As a leading notified body, LNE/G-MED will cover the following topics during this webinar:
• The regulatory context surrounding the need for sampling during Unannounced Audit
• Company type and or devices for which sampling may apply,
• A Notified Body's perspective of the requirements' implementation.

LNE GMED ARROW Click here to watch the video.

CE Marking and the Roles of Notified Bodies

What does "CE" stand for? Notified bodies have many responsibilities that extend beyond simply performing product assessments for CE Marking.

As a leading notified body, LNE/G-MED will answer the following questions:

• What is CE Marking and how does it apply ?
• The role of Notified Bodies and their responsibilities with respect to Manufacturers and the Competent Authorities.
• What is the connection between a Notified Body like LNE/G-MED, medical device manufacturers, European Competent Authorities, and the European market and what is the roles of each when it comes to get a safely performing device to Europe.

LNE GMED ARROW Click here to watch the video.

INMETRO, its Role in the Brazilian Medical Device Registration Process

INMETRO certification is a requirement for electromedical device manufacturers who wish to market their devices in Brazil, and is an additional and required step in their regulatory submission to ANVISA. But how does a manufacturer receive INMETRO certification?

Join LNE/G-MED North America in its Free webinar, INMETRO and its Role in the Brazilian Medical Device Registration Process to find out. This webinar will cover:

• What is INMETRO and its role in the Brazilian government
• Where INMETRO fits into the Brazilian medical device registration process
• The process to receive, and maintain, INMETRO certification.

LNE GMED ARROW Click here to watch the video.

Mexico Medical Device Market Access & ISO 13485 certification

Medical device manufacturers both in Mexico and around the world can leverage some of their expertise with their quality systems and products to open markets around the world. The webinar explore the following points:

• How Mexican manufacturers can leverage their ISO 13485 / COFEPRIS MGMP certificates to access other markets.
• If you have ISO 13485 and want to go to Mexico, what do you do?
• Mexico medical device regulation and registration process for manufacturers in North America and the rest of the world,
• How that process interacts with ISO 13485 and the Mexican GMP,
• If you're a device manufacturer in Mexico, the steps for CE marking.

LNE GMED ARROW Click here to watch the video.

Stand-alone software classification & regulation in Europe

Software (embedded, standalone, Apps) has become more important in the medical field. Medical software is nowadays essential because of its multiple purposes in diagnostic, therapy, monitoring and others, and must meet the Medical Device Directives essential requirements before being placed on the market. Understanding how your software is classified is essential for the success of your device in Europe and to ensure the software complies with the Directive. Classification allows you to determine what would be the control level of the Notified Body.

For the answers to the following questions, and more, you can tune to LNE/G-MED North America’s webinar on Stand-alone software classification & regulation in Europe:

• Is my software a medical device in Europe?
• How to classify my software as a medical device?
• What are the risk classes of my device according to EN 62304?
• It is possible to combine a medical device with non-medical software?
• How to classify and manage non-medical software when it is combined with a medical device?
• Which conformity assessment route for the CE marking of my software?
• What is the applicable regulation for Software as a Service?

LNE GMED ARROW

 Click here to watch the video.

Making the CE Mark Multitask: How to Enhance the Achievements of the CE Marking to Open More Markets

To market a medical device in Europe, the device must be CE-marked to show that it conforms to the European medical device regulatory requirements. However, a medical device manufacturer can re-use the items it uses to meet the European requirements to come close to or meet other international medical device regulatory requirements as well. For example, a manufacturer may not need to build completely different quality systems to meet the European, Canadian, and U.S. regulatory requirements. Likewise, some countries allow the manufacturer’s CE certificates to be an input in a shortened medical device regulatory application. 

LNE GMED ARROW Click here to watch the video.


 

Transferring Notified Bodies

Transferring notified bodies is a critical process and a manufacturer should make this decision carefully. Regardless of the reason, both manufacturers and notified bodies must take into account the guidelines governing this process, and for the manufacturer specially, when choosing which notified body to transfer, how this notified body will fit in with his certification plans. To help manufacturers learn about the requirements and give them the tools to understand and make this strategic decision, the webinar will explore the following points: 

• The reasons to change Notified Body
• The keys points for a manufacturer to consider before taking the decision to transfer NB and the prerequisites for transferring
• Introduction to the guidelines & the documents governing the transfer process
• Presentation of the technique for transferring a manufacturer’s notified body
• Changing in the labelling

LNE GMED ARROW Click here to watch the video.

The Clinical Evaluation – Demonstration of clinical safety and performance

Clinical Evaluation is key for the demonstration of the clinical safety and performance of the devices. Why is it so important? This is relevant not only before placing a new device on the market, but it is also expected that the manufacturer will monitor its clinical performance and safety as part of the Quality Management System once the device is commercialized.

• Is the clinical evaluation mandatory for all types of medical devices?
• Why is it so important?
• What is the best methodology to demonstrate and confirm the clinical performance and safety of the device as requested by EU MDD?
• What does the Notified Body look at to assess the clinical evaluation?
• How the process can be part of the Quality management system?
• What are the common mistakes to avoid?
• Will the new MD regulation introduce any new requirements in regards to the clinical evaluation?

LNE GMED ARROW Click here to watch the video.

The IVD Technical File compilation

Notified bodies and competent authorities use the technical documentation to ensure that the medical device conforms to the applicable regulations, and manufacturers use it as a living reference tool for the device. As a result, ensuring the contents are complete and updated is of utmost importance for a medical device manufacturer to maintain its devices' CE marking. For information about the contents of IVD technical file and what Notified Bodies look for in the technical file submissions, watch this webinar on:

• The requirements of the European Directive 98/79/EC of 27 October 1998 on IN VITRO DIAGNOSTIC MEDICAL DEVICES ("IVDD"),
• The different parts and documents that go into making a technical file,
• The use of the IVD technical file by Manufacturers, Notified Bodies, and Competent Authorities,
• The unique requirements and challenges of IVD technical documentation.

LNE GMED ARROW Click here to watch the video.

Evolutions in the EU IVD Regulatory Framework

The EU in vitro diagnostic medical device regulatory landscape is changing drastically. The changes of the IVD Medical Device Directive 98/79/EC (IVDD) are expecting to lead to a fully remodeled regulation impacting:

• IVD classification
• Conformity assessments
• Clinical evidence requirements
• New technical specifications, etc....

This webinar covers the major changes that we see coming in the new IVD regulatory framework, as well as a notified body's perspective on what these changes mean for an IVD manufacturer.

LNE GMED ARROW Click here to watch the video.

Understanding EN ISO 14971:2012

Risk management is a key portion of the medical device lifecycle, from design to discard. It applies to all class of devices regardless of where they are marketed. In the European Union, the Risk Management file is part of the device's technical documentation demonstrating conformance to the Medical Device Directives. As a Harmonized Standard, EN ISO 14971:2012 can be used to demonstrate conformity to the Essential Requirements. It provides manufacturers with guidelines to follow to implement their Risk management process. Changes were made to the informative annexes between the 2009 and 2012 versions of EN ISO 14971 to clarify the link between the European Directives and the Standard requirements. The points covered in the webinar will include:

• The reasons behind the revision
• The changes and relationship between the Standard and the Directives
• The main items to be taken into account to comply with the risk management requirement of the European Directive (using EN ISO 14971:2012)

LNE GMED ARROW Click here to watch the video.

Controlling Critical Subcontractors in 2014 – Regulatory Evolutions

Recent regulatory evolutions in the EU have prompted manufacturers and notified bodies to take second looks at how medical device manufacturers control their critical subcontractors and crucial suppliers. According to the standard and regulatory texts, not much has changed in the way of requirements. In practice, however, manufacturers may need to make changes to the ways they demonstrate the monitoring of the quality system in operation, including the suppliers and contractors and show that they have integrated the quality system of the critical subcontractors and crucial suppliers with their own quality system.

The webinar will include:
• A description of the requirements for controlling critical subcontractors and suppliers as it stands today,
• Some methods that manufacturers can use to prepare for the Recommendation's specifics.

LNE GMED ARROW Click here to watch the video.

Future of the IVD Directive: Expected Regulatory Change Based on European Commission

One of our Project Managers Lead Auditors in IVDs, Darren Walsh, has attended the AdvaMed 2011 conference on Tuesday, September 27. Darren has moderated the panel Future of the IVD Directive: Expected Regulatory Change Based on European Commission in room 207B at 9:00 AM. The panelists were Dr. Catherine Holzmann, Ph.D, the IVD Department Manager of LNE/G-MED and Dr. Judith Andrews, Ph.D, RAC from Medical Device Consultants, Inc. 

LNE GMED ARROW Click here to watch the video.

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