EU-MDR: Are You Ready? Part I – Webinar Recording/Transcript
EU-MDR: Are You Ready? An Exclusive Three-Part FDAnews Webinar Series
Part I: The Real Role of the Person Responsible for Regulatory Readiness & Compliance
With the new European Union medical devices and in-vitro diagnostic medical device regulations going into effect in May 2020 and 2022, the role of the Person Responsible for Regulatory Compliance (PRRC) will ensure that there is adequate supervision and control of medical devices placed in the market.
But most manufacturers and regulators are currently only concentrating upon the specific experiences and qualifications necessary for a PRRC. The duties, responsibilities, authority and organizational design necessary to ensure a PRRC can supervise and control need to be carefully considered within the context of the organization.
Does your organization have the structure and processes in place to support the PRRC and ensure compliance?
Join us for an informative webinar on Feb. 20 to get a better sense of what the PRRC does to supervise and control the change management process as well as the release of product onto the market. This webinar is the first in an exclusive three-part FDAnews webinar series on EU-MDR readiness.
During the presentation, you’ll:
- Find out why a PRRC is required in the first place and what is the PRRC duties and responsibilities
- Determine whether the PRRC is over or under qualified or unable to fulfil their duties due to tasks overload
- Get a sense of the relationship between the PRRC and the strategy set for regulatory compliance
- Discover how the processes of a medical device manufacturer and other economic operators should be planned in order to fulfil the requirements for a PRRC
- Critically evaluate whether your corporate structure is ready to ensure supervision and control of products to achieve EU regulatory compliance
- Familiarize yourself with the importance of organizational design to ensure the various roles participating in compliance are understood and coordinated
Prepare for the new PPRC requirement and get ready for the upcoming EU-MDR deadlines with the first webinar in this exclusive three-part series. Join us by registering today for Part I or save 25% by registering for the complete three-part series.
The series also includes:
- Part II: Tips for Assessing Your Readiness Prior to Notified Body Review
Thursday, March 26, 2020, 1:30 p.m. - 3:00 p.m. EDT
- Part III: After May 2020, Ensuring Your Post-Market Surveillance Readiness via a Risk Management Framework
Thursday, April 23, 2020, 1:30 p.m. - 3:00 p.m. EDT
Meet Your Presenter:
James Pink, Vice President, NSF Health Sciences Medical Devices, Europe
James Pink has more than 20 years’ experience in the medical device industry, including 10 years as a health care technology expert and Lead Auditor for a leading European Notified body. He has managed development and quality assurance programs for orthopedic, cardiovascular, wound, and combination products; and presented to the EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings. A major focus in recent years has been preparing for the advent of the EU Medical Device Regulation.
Who Will Benefit
- Medical device / technology companies
- In-Vitro diagnostic device companies
- Quality manager
- Regulatory manager
- Operations manager
- Design manager
- Technical manager
- Clinical manager
- Authorized representative in Europe