R&Q and Nerac invite you to attend a free medical device event and panel discussion titled:
Notified Body Expectations: Today, Tomorrow and into the Future
Register Today – Space is Limited!
Thursday, June 18, 2015
7:30am to 11:00am (EST)
Embassy Suites Waltham,
We invite you to join medical device professionals from GE Healthcare, MAQUET, Nerac and R&Q for a morning of information exchange covering the regulatory changes which have driven the increasing demands and changing expectations of Notified Bodies, and what companies are doing to meet compliance.
Register today and mark your calendar!
Thursday, June 18, 2015 | 7:30 to 11:00am (EST)
Embassy Suites Waltham,
7:15-8:00am Registration and continental breakfast
Overview and Ramifications of Current Notified Body Changes, Donna Mitchell-Magaldi, Nerac Analyst
State of the Art Analysis and Compliance, Ron Sills, Nerac Analyst
Medical Device Single Audit Program (MDSAP) and Unannounced Audits, Christine Santagate, Manager, R&Q
Notified Body Audit Trends, Denise Webber, VP Clinical Affairs, MAQUET
Notified Bodies from the Perspective of a Medical Director, Dr. Ron Von Jako, Medical Director-Surgery, GE Healthcare
Panel Discussion and closing remarks
We look forward to seeing you there!
Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality support to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices.
Nerac Inc. is a global research and advisory firm for companies developing innovative products and technologies. Nerac provides expert insights that equip clients with the knowledge to develop or refine a technology, explore market growth opportunities, evaluate intellectual property strategies and respond to regulatory changes. Nerac serves approximately 20,000 users worldwide and answers over 5,000 research questions each year. Nerac has a long, successful consulting history in a wide-range of industries with a strong focus in the areas of medical devices, pharmaceutical, food and nutraceuticals, engineering, energy and
Meet the Speakers
Christine Santagate, Operations Manager, R&Q
Christine Santagate RAC, is the Boston Operations Manager for Regulatory & Quality Solutions LLC. Christine’s training and experience consists of extensive experience in Medical Device Quality and Regulatory Assurance with a focus on the product development life cycle. She has experience with CAPA and complaint systems, design control processes and achieving US and International Regulatory approval (510k, PMA, CE). Christine is also a Quality auditor with wide-ranging experience auditing quality systems against ISO and QSR regulations. As Operations Manager, Christine has overall accountability to oversee company consulting operations to ensure production efficiency, high quality, excellent customer service, and cost-effective management of resources. As a Principal Advisor, Christine acts as a project leader, coordinates and participates in the development, compilation and submission of PMAs, IDEs, and 510(k)s. She also represents and supports clients in interactions with regulatory authorities.
Ron Von Jako, Ph.D., Medical Director-Surgery, GE Healthcare
Ron Von Jako has a Doctor of Medicine MD – PhD honors, Surgical fellowship and clinical research – Harvard and BU, CDRH FDA Medical Device Advisory Board Member, Adjunct Professor of Surgery, Editorial Review Board for four Medical Societies and Associated Peer Review Journals, Author of 47 Peer Reviewed Medical Articles, Six Medical Text Book Chapters, 12 Medical Device Patents, and consulted to a dozen major device companies. Major accomplishments- Founded two medical device start-ups, pioneered and licensed technology and methods which developed: – minimally invasive coronary artery bypass grafting on beating heart (MIDCAB), vascular mini-open aortobifem/aorto-iliac bypass surgeries, percutaneous – mini-open spine fusion and hip surgery, and techniques with instruments and approaches in 7 major surgical subspecialties. Member – Medical Affairs and Technology – Sr. Staff GEHC.
Denise I. Webber, BS, MSJ
Denise Webber is Vice President of Clinical Affairs at MAQUET Cardiovascular. She and her Operations teams are responsible for clinical development programs that support various cardiovascular medical device products – including pre-market and post-market trials to support safety and performance claims.
Before joining MAQUET, Denise was an independent clinical operations consultant for 6 years. During that time she partnered with various pharmaceutical and medical device Sponsors, Clinical Investigators, CROs, and other consultants to advance quality clinical and regulatory projects. She also coordinated FDA ‘readiness for inspection’ coaching and training for clinical study site personnel and industry Sponsor teams.
Denise has more than 24 years of pharmaceutical, biotech and medical device development experience. She has held various senior management positions with: Cytogen Corporation, Anthra Pharmaceuticals, Pharmacia/Pfizer and Sanofi-Aventis. Over the years, Denise has led clinical study and submission activities resulting in FDA and other Health Authority product approvals, advisory and panel meeting preparations, GCP compliance initiatives and related training programs.
Denise holds a B.S. degree in Biology and earned herMSJin Health Law and Policy from Seton Hall School of Law in 2003. Originally from Chicago, Denise spent her early career as a Nuclear Medicine Technologist working in monoclonal antibody research at Northwestern Memorial Hospital.
Of late, she “dabbles” in Triathlons, competing in half-Ironman distance races. Just for fun.
Ron Sills, MS, Nerac Analyst
Ron Sills works strategically with medical device companies to review business goals and objectives and offer information management solutions and analysis. By providing custom briefings to monitor the medical device industry, assess the competitive landscape, and track product safety, he proactively enhances executives’ ability to make informed decisions.
Donna Mitchell-Magaldi, Nerac Analyst
Analyst Donna Mitchell-Magaldi has been with Nerac for over 12 years and partners with medical device companies, serving them in many capacities. As an Analyst at Nerac, Donna has been exposed to a variety of other medical device disciplines such as cardiovascular, medical imaging, endodontics, biomonitoring and medical sensors, orthopedics, gastrointestinal and more. Over the course of the last several years, Donna has been assisting our medical device clients with meeting the MedDev 2.7.1 Rev 3 “Guideline on Medical Devices Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” and other regulatory issues, market analysis, prior art research, research to support R&D initiatives, patient landscape, FDA clinical literature support, and much more.