EU Finalizes New Medical Device Regulation

A Q1 Productions 2017 White Paper

CHAPTER ONE: QUALITY MANAGEMENT SYSTEMS

The MDR contains explicit requirements for manufacturers to establish, implement, and manage a quality management system (QMS). While ISO 13485 is not required under the MDR, it is the recognized industry standard for comprehensive product design and manufacturing and can be implemented concurrent to the Regulation. An effective QMS must contain risked-based decision making processes and procedures for complying with evolving regulations, while monitoring delegated acts that might change the essential requirements.

To read more about the aspects that the quality management system shall address, download our whitepaper.

The six topic areas we will cover include changes to the following:

Clinical
Notified Body
Quality Management
Supply Chain
Surveillance and Vigilance
Technical Files

This paper looks to provide a summarized overview of the provisions within the regulation which will impact medical device manufacturers—from CE marking and technical document management to quality management systems.

At Veranex, we can help you with concept through to commercialization by enabling:
• Accelerated speed to market
• Controlled development costs
• Development risk mitigation
• Market viability assessment

At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions.

Visit Sponsor Website

Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. 25 years later, we are proud to have helped hundreds of clients complete their projects and thousands of consultants find great assignments. We continue to focus on helping our clients and consultants as well as our community as a certified women-owned, award-winning staffing company that works exclusively with Learning & Development professionals to match consultants to client projects.

Visit Sponsor Website

TELCOR is the proven leader of health care software solutions for revenue cycle management (RCM) software and services designed specifically for laboratories. TELCOR RCM, our SaaS solution, and TELCOR Revenue Cycle Services, our billing service, are designed to streamline workflow, improve collections, and provide real-time analytics. Our software and service solutions are designed for the unique challenges and requirements of laboratory specialties and the clients they serve. With full access to data, labs have complete visibility of their data and can track key performance indicators. No other vendor works as hard ensuring you get paid for the work you do.

Visit Sponsor Website

At Tipping Point Media, we pride ourselves on developing innovative, creative, and technically advanced virtual training and digital marketing solutions for the life sciences industry.

We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates.

Our dedicated team of educators, medical experts, certified programmers, and digital renaissance innovators are committed to creating high-quality custom creations that bring your company's vision to life.

Visit Sponsor Website

VantagePoint Performance trains Salespeople to be more fluent and comfortable across different situations needing different sales approaches, and we train Sales Managers to be better coaches and team leaders, with more focus and less stress.

We’re different from the average sales training company because:

We don’t believe that one approach, one system, or one methodology is absolutely superior. All have something to offer, and the “best approach” or “best system” depends on the sales situation. This is what our applied, academic research tells us.
Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. We provide insights from each client’s data to help them understand what drives the success of their top-performing Salespeople and Sales Managers.
We are constantly feeding what we learn back into our training products, and we invest a bigger slice of our total energy into this innovation than the average sales training company. Our clients can access always-refreshed intellectual property and content through our training subscriptions.

Visit Sponsor Website

Policy Reporter, acquired by TrialCard in 2019, provides innovative healthcare software solutions to track payer policies in near real-time and enhances market access for the therapies patients need most. The company’s patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. Its clients include some of the world’s largest pharmaceutical and healthcare companies.

Visit Sponsor Website