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Register for our webinar: Post Market Surveillance & PMCF under the European MDR
May 17, 2017 to May 17, 2017

Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) adds to the complexity of complying with specific PMS and post-market clinical follow-up (PMCF) requirements. Many companies will need to maintain more robust PMS procedures and perform more PMCF studies to meet their Notified Body’s expectations. In this free webinar, we will discuss new European PMS and PMCF requirements.

What will you learn:

  • Clinical evaluation process in the post-market phase of the device
  • The role of clinical data during the lifetime of a medical device
  • The purpose of PMS in the MDR and how to perform it
  • Why, when, and how to perform PMCF
  • Tips, tricks, and pitfalls of PMS and PMCF under the MDR

ABOUT THE PRESENTER:
Ronald Boumans is a Senior Regulatory Consultant at Emergo's office in The Hague with 30+ years of experience in the medical device industry. Prior to joining Emergo, he served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGZ). Ronald’s expertise includes European medical device legislation, Competent Authority supervision, and CE Marking requirements. He is a member of the EUDAMED Steering Committee and the EUDAMED post-market surveillance, vigilance, and data exchange working groups.

Register for our webinar: South Korea Medical Device Registration
Jun 15, 2017 to Jun 15, 2017

South Korea is one of the most promising medical device markets in Asia. The Ministry of Food and Drug Safety (MFDS) regulatory process is well established, and demand for high-quality medical technology is robust. However, submission requirements are complex and it can be difficult to navigate the MFDS process, especially for regulatory professionals not fluent in Korean. In this free webinar, we will take a closer look at medical device registration requirements in South Korea.

WHAT YOU WILL LEARN:

• Regulatory structure in South Korea
• Overview of key medical device laws and regulations
• Medical device and IVD classification schemes
• Registration pathways, technical file requirements, and clinical data requirements
• Quality management system (KGMP) and in-country representation requirements
• And much more.

ABOUT THE PRESENTER

Christine Hall is the Manager, International Operations at Emergo. In this role, Christine supervises client relations and business development activities in Asia and Latin America, and spends considerable time helping clients access the Korean market in cooperation with our office in Seoul. Christine also has expertise in regulations related to Brazil, Mexico, Russia, Israel, China, and Taiwan.

Register for our webinar: Getting 510(k) Clearance for Your Device from the US FDA
Jul 13, 2017 to Jul 13, 2017

The US remains the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission, what the FDA wants to see, and how to avoid problems that delay or derail submissions. In this webinar recorded in July 2017, we cover:

  • Brief overview of the US regulatory process
  • Classification scheme
  • How the FDA uses product codes and regulation numbers
  • Role of guidance documents and types of documents
  • Testing and how to find out what your device requires
  • Document structure of a 510(k) submission
  • The "Refuse to Accept" (RTA) process – how it works
  • Additional Information (AI) requests and following up with FDA reviewers
  • Common mistakes and how to avoid a quagmire
  • Average time to clearance for specific types of devices

DOWNLOAD PDF OF FDA 510(K) WEBINAR SLIDES (opens new window)

ABOUT THE PRESENTER:

Audrey Swearingen is Director of Regulatory Affairs at Emergo's Austin, Texas headquarters. With over 20 years of experience in regulatory affairs, Audrey's areas of expertise include US FDA, European and Canadian medical device registration.

Register for our webinar: Mapping UL 2900 Cybersecurity Standards to FDA Guidance
Aug 10, 2017 to Aug 10, 2017

A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. The UL 2900 standards were developed to provide manufacturers with testable and measurable criteria to assess medical device software vulnerabilities and security controls as well as identify security improvements.

In this one-hour webinar, we discuss various aspects of medical device cybersecurity and how the new standards correspond to FDA guidance. This is particularly important for manufacturers preparing to submit new network-connected devices and software via the FDA 510(k) submission process. What you will learn:

  •  Overview of ANSI UL 2900-1: General requirements for software cybersecurity for network-connectable devices and products
  • Overview of UL 2900-2-1: Particular requirements for network-connectable healthcare system components including medical devices and software

  • Overview of how the requirements of the UL 2900 standards help manufacturers meet the FDA guidance for pre- and post-market management of cybersecurity

About the presenter:
Laura Élan is the Practice Leader – Digital Health and Cybersecurity at UL and a licensed Professional Engineer. With over 25 years of experience, her expertise includes project management, software design, and software development processes and regulatory performance. Laura holds a Master of Science in Electrical Engineering from the Illinois Institute of Technology.

This webinar was recorded on August 10, 2017.

14971 risk management webinar
Sep 27, 2017 to Sep 27, 2017

Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. Manufacturers around the world are recertifying to the new standard, which emphasizes risk management as a key component of quality management systems. EN ISO 14971:2012 defines risk management processes for medical device manufacturers. But, implementing ISO 14971 can be intimidating. In this webinar, Dr. Dieter Dannhorn breaks down the requirements of ISO 14971 compliance and explains how to strategically implement the standard into your quality system. You will learn:

• Key definitions of EN ISO 14971
• A breakdown of the risk management process
• Components of the risk management plan
• Personnel and responsibilities in the risk management process
• How to define the risk of your device
• What is a risk management report and risk management file

ABOUT THE PRESENTER:
Dr. Dieter Dannhorn is a Senior Expert for Medical Devices at UL's medical device testing division in Germany. Dr. Dannhorn has over 25 years of experience in the medical device and pharmaceutical industries, particularly in the areas of clinical research, device testing, biocompatibility, registration support, and risk management. He was the previous owner of mdt medical device testing GmbH and md registration support Ltd., which were purchased by UL in 2011. He has worked as a freelance consultant and expert for UL since 2013 and received his doctoral degree in cell biology and anatomy from The Phillip University of Marburg in Germany.

Want a copy of the webinar slides? Click here to download the PDF.

 

Emergo MDR webinar October 2017
Oct 26, 2017 to Oct 26, 2017

The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect for a few years, 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) will outline the most important changes you need to know including:

- 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...

ABOUT THE PRESENTER: Ronald Boumans is Senior Regulatory Consultant at Emergo’s office in The Hague. He previously served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGZ), and his areas of expertise include European medical device legislation, Competent Authority supervision, and CE Marking requirements.

Click here to download a PDF of the webinar slides.

THIS WEBINAR WAS RECORDED ON OCTOBER 26, 2017

Nov 9, 2017 to Nov 9, 2017

Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However, device packaging can degrade over time or become compromised during packing, transportation, distribution, storage, or handling. Many device regulators require medical device shelf-life and package testing to the ISO 11607 series of standards to ensure devices remain sterile until the barrier system is opened. In this free webinar, Marcus Corzilius, Global Service Line Leader - Medical Device Testing for UL will outline how to comply with requirements in EN ISO 11607, including:

• A review of related general safety and performance requirements (MDR)
• Key terms and definitions
• Considerations to packaging system design
• Test methods overview
• Packaging process validation
• Shelf-life study design
• And much more…

ABOUT THE PRESENTER
Marcus Corzilius is Global Service Line Leader - Medical Device Testing at UL’s office in Ochsenhausen, Germany. He previously served as Engineering Manager for UL’s European Medical Electrical Equipment safety testing team, and his areas of expertise include conformity assessment, testing laboratory operations, and process improvement.

Jan 25, 2018 to Jan 25, 2018

Twenty years after FDA first called upon manufacturers to apply human factors engineering (HFE) in medical device development, HFE has become a relatively mainstream activity. Most companies have figured out the basics of what they need to do and how to do it. Now, the challenge for medical device manufacturers is to apply HFE efficiently and effectively.

This webinar will guide you toward a better HFE approach with answers to these questions:
 
•    Is there value in establishing an in-house HFE team? Does the answer depend on company location, size, and the number and type of products?
•    Should in-house HFE teams conduct summative usability tests or engage consultants to run them?
•    Is it worth investing in learning tools (e.g., user manual, quick reference guide, “Get Started” guide, online simulations)?
•    How many rounds of formative usability testing is enough?
•    Should we build our own usability test laboratory or rent?
•    Where should an HFE team reside in the organizational hierarchy?
•    How much user research is necessary when developing a global product?
 
ABOUT THE PRESENTER

Michael Wiklund serves as general manager of UL's human factors engineering practice, which includes staff working in the USA, Europe, and Asia. A certified human factors professional, he has a over 30 years of experience in the field, much of it focused on medical technology development. Michael has authored many books on human factors engineering, the latest being the second edition of Usability Testing of Medical Devices and Medical Device Use Error – Root Cause Analysis. In early 2018, AAMI will publish his latest book titled, Writing Human Factors Plans & Reports for Medical Technology Development. He has also contributed extensively to the current AAMI and IEC standards and guidelines on human factors engineering. As Professor of the Practice at Tufts University, he teaches courses on applying human factors to medical technology to meet regulatory and commercial imperatives.

CER Complience webinar EMERGO 2018
Feb 21, 2018 to Feb 21, 2018

Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and Competent Authorities in Europe. That scrutiny – and the burdens placed on medical device manufacturers – leaves some companies at risk of losing their CE certifications following routine Notified Body re-certification audits. In this free webinar, we will examine the clinical data and literature review requirements found in MEDDEV 2.7/1 revision 4 as well as the changing regulatory environment as it relates to these requirements.

WHAT YOU WILL LEARN:
• Clinical data requirements in the MDR and MEDDEV 2.7/1 revision 4
• How to determine whether a device is equivalent to your own
• Requirements on searching for literature and whether your clinical literature reviews will be accepted by your Notified Body
• Collating and appraising the data
• Documenting your evaluation
• Updating your CERs and the importance of PMS data
• Looking to the near future - clinical data requirements in the MDR

ABOUT THE PRESENTER:
Jane Arnold‐Round has 25 years of experience in the medical device industry. She has held technical and regulatory positions with Medtronic, Sulzer Vascutek, AstraZeneca and BSI, the UK Notified Body. During her tenure with BSI, she gained extensive experience in reviewing technical files and design dossiers (including CERs) and was responsible for classification, borderline issues for medical devices utilizing animal tissue and numerous drug‐device combination design dossier reviews. Jane has been a Senior Consultant on our UK team since 2004, assisting hundreds of device clients with CE, risk analysis, biocompatibility and, of course, endless issues related to clinical data.

This webinar was recorded on February 21, 2018.

 

Brazil registration webinar 2018
Mar 22, 2018 to Mar 22, 2018

Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a tumultuous economic and political future presented uncertainties for foreign manufacturers. However, ANVISA released numerous regulatory updates in 2016 to make Brazil a more accessible medical device market. For companies currently selling in Brazil, this also means new rules for staying in compliance with ANVISA’s requirements. In this free webinar, we will examine current medical device registration requirements in Brazil and recent regulatory changes.

WHAT YOU WILL LEARN:
• Overview of recent regulatory changes and current ANVISA registration requirements for medical devices
• Brazil Registration Holder requirements and registration transfers
• Brazil GMP requirements and MDSAP option
• New INMETRO compliance rules and deadlines
• Clinical data requirements for higher risk devices
• ANVISA review timelines and expedited registration routes

ABOUT THE PRESENTER:
Ann Marie Boullie has over 10 years of experience in the medical device industry, with expertise in regulatory requirements and strategy in major Latin American and Asian markets. As Global Operations Manager, Ann Marie oversees Emergo’s project management team worldwide, and has operational oversite for offices such as Brazil, Mexico, the Netherlands and more. She has helped medical device clients register their products with regulators in Brazil, Mexico, Russia, Korea, and Japan since joining Emergo in 2006.

webinar - risk management landscape April 2018
Apr 19, 2018 to Apr 19, 2018

Regulatory expectations for medical device risk management are evolving toward the need for “mature” systems and processes. Recent standard revisions also emphasize patient safety - a key enabler for participating in new and emerging regulatory schemes, such as the MDR and the FDA Digital Health Software Pre-Cert Program. To meet these expectations, device companies must learn to leverage risk management tools to improve patient outcomes, as well as patient and user benefits.

A mature risk management system satisfies more than the moral imperative of reducing risk for patients and users. It can increase device sales and customer loyalty, reduce the chance of product liability claims, and reduce your time to market. In this webinar, Mark Leimbeck will discuss how the regulatory environment is changing and what this means for your company. You will learn:

  • A general overview of ISO 14971
  • How specific standards reflect new risk management expectations, including IEC 60601 – Medical Devices, ISO 13485 – Quality Management Systems, IEC 62366 – Human Factors Engineering, IEC 62304 – Software, and more
  • Areas of your risk management system that will receive more scrutiny from regulators
  • What this new era means for post-market surveillance and your suppliers

ABOUT THE PRESENTER:

Mark Leimbeck is a Program Manager for UL Health Sciences with more than 30 years of experience working in roles including Operations Manager, Program Manager, and Principal Engineer. He is responsible for developing new services, training, and representing UL on International standards and other technical development committees. Mark holds a bachelor’s degree in Electrical Engineering Technology from Southern Illinois University and a master’s degree in Business Administration from the University of Chicago.

 

Libary card - US FDA de novo webinar - May 2018
May 24, 2018 to May 24, 2018

The US FDA medical device classification scheme presents some unique challenges for new technology. With a system based on equivalence, manufacturers of new and novel devices face a rigorous market entry process usually reserved for high-risk, Class III devices. However, some novel devices qualify for the FDA de novo process, which allows products to enter the market as Class I or Class II depending on their risk to users and patients. 

In this webinar, Audrey Swearingen, RAC will discuss the benefits and criteria of the US FDA de novo program and how qualifying device companies can pursue this pathway to the US market. You will learn: 

• What is the de novo process? 
• How to determine if it is applicable to your device 
• Communicating with the FDA via the Pre-Submission program 
• Content of a de novo application 
• FDA review process 

ABOUT THE PRESENTER: 
Audrey Swearingen, RAC (US) is the Regional RA Manager at Emergo by UL’s Austin, Texas headquarters. With over 20 years of experience in medical device regulatory affairs, Audrey’s areas of focus include US FDA device premarket registration, device labeling and promotion compliance, and risk assessment. Other areas of expertise include FDA human tissue regulations, as well as European CE marking and Canadian device license applications. 

Register: Eudamed Webinar July 2018
Jul 11, 2018 to Jul 11, 2018

As it prepares to meet new regulatory requirements in Europe, the medical device community is also following developments about the European Database for Medical Devices, or Eudamed. Eudamed is a publicly-accessible database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Frequent interaction with Eudamed will be required for manufacturers, authorized representatives, importers, and sponsors, who must follow clear rules about what information and when to upload about their devices. If you are selling a medical device in Europe, it will be important to understand and comply with these requirements.

In this webinar, Ronald Boumans will discuss the role of Eudamed in MDR/IVDR compliance. You will learn:

  • An overview of Eudamed’s functional specifications and the proposed transition plan
  • When and how to exchange data with Eudamed as well as how this exchange will be monitored
  • Who should access Eudamed and how this access will be granted
  • How Eudamed will integrate with the Unique Device Identifier (UDI)
  • A timeline of the Eudamed release schedule, which is targeted to begin in March 2020
  • And much more

ABOUT THE PRESENTER

Ronald Boumans is Senior Regulatory Consultant at Emergo’s office in The Hague. He previously served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGJ), and his areas of expertise include European medical device legislation, Competent Authority supervision, Notified Body search, and CE Marking requirements.

WATCH NOW: Overview of the MDSAP Certification Process
Aug 31, 2018 to Aug 31, 2018
The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device regulatory authorities in jurisdictions around the world. Under the MDSAP, a single audit performed by an authorized Auditing Organization (AO) can meet quality management system requirements in the US, Canada, Japan, Brazil, and Australia. 
 
Health Canada will only accept MDSAP certificates starting in January 2019, which is motivating some companies to pursue MDSAP certification before the end of the year. But many companies are beginning to see it as a way to manage costs and ease market access. In this webinar, technical consultants Daryl Wisdahl and Ken Pilgrim discuss the benefits and potential challenges of MDSAP certification. You will learn:
 
- A brief history of the MDSAP
- MDSAP certification requirements and ISO 13485
- QMS requirements in MDSAP member markets
- An overview of the audit process
- Key factors to consider when defining the scope of your audit
- Our real-life observations from recent internal audits
- Potential challenges during the audit process
 
You will learn all this and more in this one-hour live webinar.
 
ABOUT THE PRESENTERS:
Ken Pilgrim is a Senior Technical Consultant for Emergo by UL and is located in Canada. With more than 20 years of experience in quality management, his expertise includes ISO 13485, MDSAP, and CMDR implementation and audits as well as medical device registration submissions in Canada, the EU, and US. 
 
Daryl Wisdahl is a Senior Technical Consultant for Emergo by UL based in Seattle. Daryl has over 20 years of experience in the medical device industry, including Medical Device Licensing in Canada, QMS implementation and audits, and preparing US FDA 510(k) submissions.
 
Sep 25, 2018 to Sep 25, 2018

Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination product manufacturers face some unique challenges because their products are subject to HFE requirements for devices, drugs, cosmetics, or more. In this webinar, we will provide an overview of HFE considerations for combination products. You will learn:

  • Introduction to Human Factors Engineering (HFE)
  • Regulatory imperative for applying HFE (per FDA, IEC 62366, MHRA) 
  • Combination product specific guidance for new drugs, generics, and interchangeable biosimilars
  • Key HFE tasks and estimated timelines
  • Case studies and lessons learned

ABOUT THE PRESENTER

Frauke Schuurkamp received her B.S. in Applied Psychology from the Saxion University of Applied Sciences and her M.S. in Human Factors & Media Psychology from the University of Twente. After completing her human factors training she joined the HFRD team, where she contributes to user research and usability testing projects.

Sep 27, 2018 to Sep 27, 2018

Mexico is one of the largest medical device importers in the world, making it an attractive market for foreign companies. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) is responsible for the review, approval, and post-market monitoring of any healthcare product in Mexico. However, regulatory requirements are complex, and it can be difficult to identify the most efficient submission route for your products. In this free webinar, we will examine current medical device registration requirements in Mexico and recent regulatory changes. 

WHAT YOU WILL LEARN: 

• Regulatory structure in Mexico 
• Overview of key medical device laws and regulations 
• Medical device and IVD classification schemes and registration pathways 
• Testing and clinical data requirements 
• Quality management system and in-country representation requirements 
• And much more 

ABOUT THE PRESENTER: 
Ann Marie Boullie has over 10 years of experience in the medical device industry, with expertise in regulatory requirements and strategy in major Latin American and Asian markets. As Global Operations Manager, Ann Marie oversees Emergo’s project management team worldwide, and has operational oversite for offices in Brazil, Mexico, the Netherlands and more. She has helped medical device clients register their products with regulators in Brazil, Mexico, Russia, Korea, and Japan since joining Emergo in 2006.