Best practices and critical guidance on every step needed to sell your active medical device in the US, CAN, EU, and international markets.

October 18, 2018

Forefront Center Waltham/Boston, MA

9:00 am - 5:00 pm

The medical device industry is one of the most heavily regulated industries with requirements across the world being multi-faceted, diverse, and very stringent (to ensure the safety of patients). Each country has its own detailed regulatory requirements for medical devices which are continuously revised and updated to ensure the safety of patients while also addressing issues with increasingly complex and constantly evolving device designs.

Not only do today’s medical devices typically consist of unique combinations of mechanical, electrical and electronic technology, but now digital technology, such as wireless connectivity, smart devices, and mobile apps have enabled us to utilize software to process medical/healthcare information which has introduced new vulnerabilities and increased concerns for medical cybersecurity. Medical device manufacturers face a number of unique and complex challenges in achieving compliance when introducing devices onto the market whether selling in the U.S., CAN, EU or international markets.

This seminar will help you at every point of the product lifecycle from development to market entry including: Understanding Global ME regulations and market access requirements (US NRTL/FDA, EU MDD, IEC CB Scheme); Compliance testing; Implementing good risk management and performing post-market surveillance; Handling data and documents for regulatory submission. You will learn critical knowledge from our in-house compliance experts and FDA regulatory specialist about regulatory compliance requirements and FDA regulations for Medical Devices according to IEC 60601-1-xx family of standards, ISO 14971 standards, Incorporating Risk Management, EU Medical Device Directive, Cybersecurity and more.

About this Seminar

This seminar will »

  • Provide critical guidance on requirements and documentation to successfully submit and achieve FDA, EU Medical Device Directive (MDD), IECEE CB Scheme medical device approval.
  • Explain how existing and upcoming standards, certifications and their implementation are developing to incorporate risk management and risk analysis.
  • Evaluate methodologies and design techniques adopted to ensure quality assurance for successful compliance.
  • Evaluate both emissions and immunity aspects of medical product design for electromagnetic compatibility compliance according to IEC 60601-1-2 4th Edition.
  • Explain significant changes to specifications of immunity test levels according to the environments of intended use harmonized from IEC 60601-1-11.
  • Determine the applicable requirements to design for Product Safety and EMC compliance.

Who should attend:
Medical Device Industry Managers, Project Engineers, Product Managers, Quality Assurance professionals, or Technical Consultants involved in design and development of medical devices.


Topics Covered »

  • FDA 510(k) submissions vs PMCF data for CE Marking
  • Best practices and compliance considerations when designing for Product Safety and Electromagnetic compatibility (EMC) compliance according to IEC 60601-1 series:
    • Intro to IEC 60601-1 series with Collateral & Particular Standards
    • Design & compliance to IEC 60601-1 3rd edition; IEC 60601-1-2 4rd edition
    • Changes to the 60601-1 series and supporting standards: Updates on what’s new and draft documents that may impact your compliance strategy
  • Classification of ME Equipment & ME Systems and environments of intended use according to new harmonized requirements of IEC 60601-1-11.
  • Electromagnetic compatibility requirements of ME Equipment and ME Systems according to IEC 60601-1-2 collateral standard.
  • Risk Assessment, Best practices for designing a Risk Management system according to ISO 14971.
  • Marking and labeling, Documentation, user manuals, instructions for use (IFU).
  • Cybersecurity in Medical Devices

Working with the FDA: FDA 510(k) vs. CE Marking Submissions
The European Commission’s response to the PIP scandal has increased the cost of CE marking in Europe, reduced the number of Notified Bodies by half and forced device manufacturers to begin collecting clinical data for moderate and low-risk devices. In the future, we should expect more companies to seek 510(k) clearance first. This presentation explains how to alter launch strategies for new devices to embrace the new regulatory landscape.

Developing a Test Plan to Meet DHF Requirements
When addressing FDA’s requirements for design controls, the regulations can seem frustratingly vague in defining what testing is needed to ensure the product design will meet its intended use. Turning to the thousands of published standards can be equally confusing, leaving design engineers with a lot of decisions to make in preparing a test plan for their Design History File. In this session, Christopher Scott will discuss the considerations that must be taken into account in order to navigate this complex landscape to a successful regulatory approval.

Securing Medical Devices in Today’s Evolving Cybersecurity Landscape
Cyber threats are evolving and expanding at an astonishing pace. The attack surface has expanded to every area of modern life, including our homes, cars, and healthcare facilities. Protecting our critical infrastructure and vital systems, such as medical devices, has become of paramount importance. The path forward isn’t clear; however, by leveraging risk-based approaches, accepted industry standards, and manufacturing processes that consider cybersecurity throughout the system development lifecycle, we will pave the way forward, so society can safely benefit from technology’s many advantages.

60601-1 3rd edition and Risk Management: Product Safety Certification
Product Safety requirements of ME Equipment and ME Systems according to IEC 60601-1 3rd Edition with critical insights into significant differences when compared to previous editions, risk management and the manufacturer’s responsibility, mandated use of collaterals, Part 2 standards, as well as standards and regulatory activity with respect to the United States, FDA and OSHA, Canada and Health Canada, Europe, CB Scheme, participating and countries.

Electromagnetic Compatibility of Electrical Medical Products
IEC 60601-1-2 4th Edition introduced significant technical revisions such as risk analysis and immunity requirements. Significant changes include specification of immunity test levels according to the environments of intended use, which are categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments. This presentation with give you an overview of IEC 60601-1-2 4th Edition with critical insights into emissions and immunity aspects of medical product design, the revamped classification system based on the environments of intended use, and risk management


About the Presenters

Wade Munsch – Eurofins | MET Labs
Wade has nine years of experience working in product safety for various laboratories including his current position at MET Laboratories, Inc. He has a Bachelor of Science degree in Electrical Engineering from the University of Texas at San Antonio and currently holds a Product Safety Engineer Certification with iNARTE. During his career, his focus has been on medical electrical equipment both second and third editions.

Christopher Scott – Eurofins Medical Device Testing
Christopher Scott has spent nearly 30 years in the medical device industry working for prominent global organizations, as well as running several start-ups. He has worked across a range of sectors including cardiovascular, orthopedics, general surgery, dental, and robotics. Currently, Mr. Scott is Vice President for Eurofins Medical Device Testing, an organization with 16 laboratories around the world providing a broad portfolio of testing services focused on the needs of medical device companies.

Sean Walls – Eurofins Cybersecurity
Mr. Walls is currently the Vice President of the Cyber Security division at Eurofins, a multi-billion dollar international QA and standards testing organization. He has over 20 years of experience in cybersecurity and information technology. Sean has held executive leadership positions with several national security consulting and IT integration companies. He has been a strategic advisor to hundreds of fortune 500 and 100 companies over the years and speaks regularly on cybersecurity subjects.

Rob Packard
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering and was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob thoroughly enjoys training others and his specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions.

Paolo Dentis – Eurofins Product Testing Italy
Paolo Dentis holds a degree in Physics and has worked in Eurofins Product Testing Italy Srl since 1992. He started his career as a technician and was involved in testing, products & workplaces safety verification activities. From 1999-2010, Paolo was appointed as Accreditation Manager of the Notified Body. During this period, he was involved in several Directives & Regulations and in the laboratory accreditation. In 2010 he was appointed as Medical Device Certification Responsible, which is the main role currently he covers.