Webinars

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

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.

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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

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

Join GMED 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.

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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

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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.

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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.

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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.

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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

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Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers

GMED is exploring during this webinar the following points:

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

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

GMEDis 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

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Embedded Software in Medical Device: Common Regulatory and Quality pitfalls

GMEDwill 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.

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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

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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

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

In order to help you comprehend these changes, GMEDwill 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?

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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. 

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

GMEDNorth 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. 

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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

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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.

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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

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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

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