Device Changes, FDA Changes, and the 510(k) Web Conference by Compliance4all

  • 150.00 Dollar US$
  • Published date: November 11, 2016
    • Online, California, United States

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Areas Covered in the Session:
U.S. FDA device clearance / approval
FDA's and EU's emphasis
Product changes and filing a new 510(k) - who's responsible
Tracking and evaluating changes - the "tipping point"

Who Will Benefit:
Senior management, project leaders, internal / external consultants
Regulatory affairs
Quality systems personnel / QAE
R&D and engineering staff

Speaker Profile:
John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Event Link :
Twitter Follow us –
Facebook Like us –
LinkedIn Like us –

Result 0 votes
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Turn a Culture of Quality Into a Competitive Advantage

    Turn a Culture of Quality Into a Competitive Advantage

    Other Services Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but can be purposefully nurtured and developed. Why should you Attend: Every organization has ...

  • Audit Trail Generation and Review 2019

    Audit Trail Generation and Review 2019

    Other Services Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. Why should you Attend: Attendees will learn how...

  • Flavors-Fragrance Synthesis

    Flavors-Fragrance Synthesis

    Other Services Shirley (New York) February 11, 2019 Check with publisher

    Flavors and fragrances have been composing the integral components of a broad range of consumer goods and even some kinds of pharmaceutical products. The wide application of these aroma chemicals significantly enhances the pressure of supplying to me...