Webinars

EUDAMED just kicked off! Ready? Set? Or Need to get started?
The EU Commission Decision for EUDAMED, the European Databank for Medical Devices (to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on invitro diagnostic devices is now live and effective from Dec 1st 2020.

The IT system consist of a total six modules, among which the first one is the Actor registration module. The European Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional. Meanwhile as an Economic Operator or a non-EU manufacturer, the EUDAMED database is to ensure the increase in transparency for medical devices and to improve coordination between member states.

Through this webinar, participants will be able to focus exclusively on “Actor Registration Module” which is key to accessing and using EUDAMED. Participants will learn how to proceed with actor and user registration and management, data to be stored, and the general validation process to receive an SRN.s.

Key Take-Aways:

1. Who are the ACTOR’s and what are their roles in EUDAMED.
2. What is meant by SRN and how to decode the SRN
3. Understand the Actor registration process
4. Different Modules of EUDAMED
5. Countries available in EUDAMED from December 2020
6. Person Responsible for Regulatory Compliance (PRRC) and their responsibilities in EUDAMED

NOW AVAILABLE ON-DEMAND

For medical device manufacturers and CMOs, the functions of planning, manufacturing, quality, safety, inventory management, procurement, and logistics are shifting from an emphasis of optimizing each discrete function to a more holistic cooperative approach that optimizes the end-to-end supply chain. A strong working relationship between suppliers and manufacturers not only delivers cost savings, it also minimizes inventory availability problems, production and shipping delays, as well as quality and safety issues—and that means a better product and more reliable services provided to your customers. Trust will lead to better relationships. And better relationships will lead to better business practices and growth.

Speakers:
 

• David Stephans, Chief Revenue Officer, Rootstock Software
• Nikki Willett, Chief Strategy Officer, ComplianceQuest
• Prashanth Rajendran, Chief Executive Officer, ComplianceQuest
• Lou Sanatore, Senior Solution Engineer, ComplianceQuest
• David Burton, Senior Solution Architect, Rootstock Software
• Bernal Rodriguez, CEO, ITEK

NOW AVAILABLE ON-DEMAND

The submission process to the FDA can be a stressful and uncertain time for a medical device company. Delays in getting your device to market can cost millions of dollars in revenue. Changes to standards, new guidance documents, and review variability all add to the stress of a submission. The FDA pre-submission process can help reduce the stress and answer questions related to your specific device. 

In this webinar we will cover what the pre-submission process is, how to initiate a meeting, and how to prepare and run the meeting to gain the best results. We will highlight tips we have used to make partnering with the FDA a rewarding experience. 

Join Thor Rollins and Matthew Jorgensen; PhD, DABT, as they cover:
 

• What is a pre-submission meeting (Q-sub) with the FDA?
• How do you set a Q-Sub?
• How do you deliver your plan during a Q-Sub?
• What is the meeting flow?
• Can I challenge the FDA?
• How do I get the most from the Q-Sub?

SPEAKERS:

Thor S. Rollins, B.S., RM (NRCM) 

Director, Toxicology and E&L Consulting, Nelson Labs

Matthew R Jorgensen, PhD, DABT 

Expert in Chemistry, Biocompatibility, and Toxicology for Medical Devices, Nelson Labs

• Quickly react and respond to the increased demand
• Empower their remote workforce
• Synchronize their supply chain
• Identify delays and bottlenecks in their manufacturing process
• Rearrange production schedule to meet delivery dates
• Ensure timely reviews of CARs, CAPAs and compliance documentation

NOW AVAILABLE ON-DEMAND

Porous polymers are the unknown science behind many of the products used in the fight against the COVID-19 pandemic. From diagnostic tests to UV disinfection chambers and countless other applications, the different types and functions of porous polymers can be used to improve product performance and flatten the COVID-19 curve.

Perfect for design and manufacturing engineers who have either a potential product concept or need to improve an existing product, this webinar will explore the science behind specific applications being used to flatten the COVID-19 curve and how to pick the materials most suitable for your design needs. Specifically, the following topics will be addressed and explored.
 

• Diagnostic testing components recommended by the CDC test protocol for COVID-19 sample collection and analysis

• Diagnostic testing components approved or in process with FDA to allow patient testing at the point of care

• Microporous PTFE solutions for UV reaction chambers to increase disinfection

• Foam solutions for N95 masks and other personal protection equipment (PPE)

• Infection prevention solutions for use in hospitals to prevent healthcare-associated infections of frontline healthcare workers and patients

• Ventilator component solutions that improve the safety, performance and patient outcomes of ventilator systems

• Filtration, wicking and venting solutions across blood management and drug delivery devices

NOW AVAILABLE ON-DEMAND

This webinar will bring together several members of industry to discuss the impact the COVID-19 pandemic has had on the medical device manufacturing supply chain. The panel will engage in a roundtable-style discussion to determine what damage has already been done, and what they expect in the months or even years ahead. Will the industry have a return to normalcy soon after the dust settles or will the effects of this linger for quite some time? Find out what these individuals foresee and pose your own questions to them to get their insights.

Speakers: 
 
Anthony S. Freeman, 
President, A.S. Freeman Advisors LLC
 
Todd McCaslin
Global Sourcing Director, Boston Scientific Corporation
 
Matthew Robida
Vice President of Corporate Development, Spectrum Plastics Group

Sean Fenske (Moderator)
Editor-in-Chief, MPO/ODT

NOW AVAILABLE ON-DEMAND

Porous polymers are the unknown science inside many of the products we use every day, providing key functionalities to products as diverse as coloring markers and diagnostic tests. Join Avi Robbins, Porex vice president of product development and R&D, as he helps attendees explore how porous polymers can improve product performance across diverse healthcare applications from medical devices to diagnostics to wound care - and help them achieve market differentiation.

Perfect for design and manufacturing engineers who either have a potential product concept or need to fix a problem with an existing product, this webinar will explore the science behind porous polymers and how to select the right type of material for your application. Attendees will learn about the differences between the three core technologies of porous polymers – sintered particles, bonded fiber, and open-cell foam – and how they are used inside finished products in the healthcare industry to absorb, apply, diffuse, filter, vent, or wick. Achieving each of these functionalities requires different technical considerations for both designing and assembling the porous component into the final product.

By understanding more about the science behind each type of porous polymer and functionality, engineers will learn where porous polymers can play in various applications and what to consider when designing their products in order to determine the best solution.

• Learn the differences between the three core technologies of porous polymers – sintered plastics, bonded fiber, and open-cell foam
• Learn why pore size and pore volume matter to the end application
• See the technology in action in specific application examples