RAPS Philadelphia Chapter: 21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices Webcast

15 February 2017
12:00–1:30 pm EST

The RAPS Philadelphia Chapter invites you to participate in a 90-minute webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.

All medical device manufacturers supplying medical devices to the US are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, also known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management syste. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

  • At a Glance
  • Objectives & Audience
  • Speaker
  • Registration Info
  • Cancellation

At a Glance


Wednesday, 15 February 2017 (12:00–1:30 pm EST)


This program is a webcast.

RAC Credits:

1.5 RAC recertification credits upon completion of the webcast/program.

Registration Fees:

Registration to 13 February 2017
RAPS Members: $25
List: $35


How Does It Work:

For the best webcast experience, please use Google Chrome browser. RAPS Webcasts are also mobile and tablet accessible for your convenience. You will receive instructions on how to log in 48 hours prior to the start of the webcast. A live Q&A portion with the speaker(s) will follow the presentation and the on-demand recording can be accessed for up to one year.


At the conclusion of this webcast, you will be able to:

  • understand design input requirement categories and qualities
  • understand the relationship between design input requirements, design output and design verification
  • understand design verification basics
  • be aware of tools and techniques to support new product development

Who Should Attend

  • This program is intended for regulatory and quality professionals from medical devices and diagnostics companies.


Tiea Theurer, MT(ASCP), MPA, lead auditor, TUV Rheinland of North America, Inc.

Registration Info

Registration to 13 February 2017
RAPS members: $25
List: $35

» Registration Online

» Registration Form (PDF) - for registration by mail or fax 

Other Information

One login provided per registration. Duplicate logins will be removed from the webcast room.

Individuals wishing to register after the registration deadline,may register only by phone.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email  raps@raps.org.

If you are not a member or an existing RAPS customer, you will need to create an account to purchase this item.

Program Contact

Suchi Basu, PhD, RAC, co-chair, RAPS Philadelphia Chapter
Natalia Remmel, PhD, RAC, RAPS Philadelphia Committee





RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing or by calling customer service. Supporting documentation is required and must be received by the deadline specified. Chapter events with registration fees less than $100 will not be refunded. For events that exceed this amount a 20% cancellation fees will be assessed.


Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org


Substitutions may be accepted with written approval from RAPS.