Date(s) - 11/11/2019 - 11/14/2019
WTC Conference Center: Room B
*** NEW COURSE UPDATES ***
Course A: Biocompatibility of Medical Devices 3-Day Certification Course
Date: 11 – 13 November 2019
Price: $1,650 USD
The recent release of ISO 10993-1:2018 and the upcoming Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring new challenges for medical device manufacturers. This course is structured to be hands-on and is designed for those who require a working knowledge of biocompatibility or are looking to update and sharpen their skills. Participants can expect to learn how to use standards to establish a biological safety evaluation plan and document and implement their plan. Use of material/chemical characterization and risk assessment will be highlighted, as will real-world exercises to practice evaluating biological risk. (In order to be certified as a biological safety specialist, participants must attend and complete all exercises over the 3-day course).
Upon course completion, attendees will be able to:
- Apply the principles of ISO 10993-1:2018 to their particular challenges with medical device biocompatibility
- Discuss the FDA guidance for biological safety and distinguish where the FDA and other regulatory bodies differ
- Prepare to upgrade device technical documentation to meet the European Union’s (EU) MDR 2017/745 GSPR
- Answer the question: When is testing not the only option?
- Distinguish the difference between evaluation and testing. Recognize when testing is absolutely necessary and how to avoid unnecessary testing.
- Select chemical and biological tests and understand how to choose among various methods
- Utilize material/chemical characterization information with the use of toxicological risk assessment to demonstrate biological safety
- Develop a program that guides your device on the regulatory path and reduces time to market
- Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan
Workshop: Navigating The EU’s Medical Device Regulation (MDR) Changes
Date: 14 November 2019
Price: $550 USD
The EU’s new Medical Device Regulation (MDR), which entered into force on 26 May 2017, builds on the framework of the existing Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMD). Now is a critical time for manufacturers as they prepare for conformity by the mandatory compliance date of 26 May 2020.
The MDR brings multiple challenges for global medical device manufacturers, including limited time to understand and implement the requirements for CE certification and business continuity. With the continued lack of guidance and interpretive documents from key stakeholders, manufacturers must make progress with their best interpretations of current expectations.
This 1-day workshop, prepared by experts who have previously worked for leading EU Notified Bodies, will provide in-depth information for medical device professionals who have a basic knowledge of the CE Mark process under the existing MDD and AIMD regulations.
Upon course completion, attendees will be able to:
- Relate the changes in the MDR to company planning, priorities and portfolio
- Consider current guidance and areas of uncertainty, with recommendations for best practice approaches
- Review strategies for maintaining CE certification using the existing directives under transitional provisions
- Demonstrate how relationships with supply chain partners will change
- Identify problems that may arise with specific devices, company quality systems and resources
- Develop and assess progress against the transition plan for implementing changes
Register for both Course A & MDR Workshop and save!
|Sylvie Framery, Senior Principal Biological Safety Scientist, holds a Ph.D. in Biology. She has been working for more than 15 years with NAMSA, with experience primarily focused on the pre-clinical evaluation of medical devices. Based in the French NAMSA Laboratory, she serves as Subject Matter Expert in support of Medical Research Managers and Technical Advisors. She is the author of multiple documents including Biological Safety Plans, Biological Risk Assessments, Toxicological Risk Assessments, Gap Analyses, and Expert Reports as well. She provides regularly training sessions in Europe to medical devices manufacturers and Notified Bodies. She provides consulting services to manufacturers with biocompatibility projects for worldwide market approvals and supports them during on-site meetings with regulatory authorities. She is also an active member of the ISO/TC 194 committee.|
|Dr. Nicolas Martin, Principal Medical Research Scientist, joined NAMSA in 2012. He holds an Engineer Degree in General Chemistry from École Supérieure de Chimie Physique Électronique de Lyon (France) and a PhD in Organic Chemistry from the University of Birmingham (UK). His expertise includes organic, analytical and industrial chemistry, material and chemical characterization, with over 8 years research laboratory experience.|
|Adrian Keene, Director of Product Development Strategy and Manager, EMEA Regulatory and Quality Services at NAMSA, utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He has worked with a broad range of devices, including drug-device combination products. Adrian was previously the Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In total, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.|