IMPLICATIONS FOR MEDTECH COMPANIES WITH FDA ROLLOUT OF THE NEW QMSR TO REPLACE CURRENT QSR

Tuesday, November 15, 2022 | 10 AM Central US Time

Brian Nguyen, SME, Medical Device QA RA
Celegence

FDA issuance of the new Quality Management System Regulation (QMSR) to industry is meant to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) with an incorporation by reference (IBR) to the 2016 edition of ISO 13485. FDA adoption of the ISO standard comes with some modification to maintain its statutory and regulatory framework. The transition is meant to be seamless as the ISO requirements are substantially similar with the QSR, however, such transition doesn’t go without possible impact to the existing QMS for integration and implementation of the new regulation.

PRICING
This webinar is complimentary.

TARGETED AUDIENCES
Dx Clinical & Regulatory
EU Dx Clinical & Regulatory
EU MD & Dx Quality
EU MD Regulatory
MD Quality
MD Regulatory
MD Supplier Quality

INDUSTRIES REPRESENTED
Medical Device
Diagnostic

Presenter:

Brian Nguyen
SME, Medical Device QA RA
CELEGENCE

Our speaker today is Brian Nguyen. He has worked in the medical device industry for more than 25 years in companies of varying sizes with class I, II, II devices. He contributed to start-up and major medical device companies in building and maintaining the Quality System. He has a Bachelor in Engineering and Masters in Business Administration and has certification to ASQ: CQA, CQE, CQM/OE, CMDA, CSQP and Certified auditor/lead auditor ISO 9001:2000/ISO 13485:2016 Dekra/Exemplar formerly RABQSA.

For More Information, Contact:

Alexia Lynch
Division Director, Life Science Programs
+33.953.444.909
alynch@q1productions.com

CONTACT US
Q1 Productions
101 W Grand Ave Suite 200
Chicago, IL 60654
T: +1 (312) 822-8100
hello@q1productions.com

COMPANY
About Us
Contact Us
Blog
Attendee Stories
RAPS Credits
Privacy Policy
Mailing List

INDUSTRIES
Medical Device
Diagnostic
Pharmaceutical
Life Science
Food and Beverage
Healthcare

PRODUCTS & SERVICES
Conferences
Webinars
Forums
Hotel Sourcing

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

Upcoming Webinar

IMPLICATIONS FOR MEDTECH COMPANIES WITH FDA ROLLOUT OF THE NEW QMSR TO REPLACE CURRENT QSR

Tuesday, November 15, 2022 | 10 AM Central US Time

Brian Nguyen, SME, Medical Device QA RACelegence

Sponsored By:

Presenter:

For More Information, Contact:

Brian Nguyen, SME, Medical Device QA RA
Celegence