Skip to content
menu-icon-lq
close-icon-lq
QMS

US FDA 21 CFR Part 820 (QSR)

Labquality has great expertise with quality systems, including the USA Food and Drug Administration Quality System Regulation, QSR, 21 CFR Title 820.

What are the QSR requirements?

Any company that want to sell their medical devices in the United States has to be compliant to FDA quality system regulation 21 CFR Part 820 (QSR). The QSR set the requirements for quality management system and are similar to ISO 13485 requirements. However, there are certain differences. The FDA QSR is a US law that needs to be followed, whereas ISO 13485 status is not similar in the EU.

management-26-768x333
separator-cyan-thickness2

Quality System Regulation 21 CFR 820

According to the regulation, manufacturers shall

  • Establish that the quality system is consistent with the complexity of the device, manufacturing processes and size, and the complexity of the manufacturing facility
  • Plan to define and implement effective procedures
  • Implement what has been documented and is going to be done
  • Check the system and make necessary changes (CAPA)
  • Act upon changes and ensure they are implemented
labquality-frame-blue (2)

Labquality

How can we help?

Labquality can assist you on
  • Planning the QMS together with the manufacturer according to the QSR regulation
  • Helping the manufacturer identify all processes needed for their QSR
  • Preparing the Quality Manual, QMS process descriptions, templates, databases, and other documentation needed together with the manufacturer
  • Helping the manufacturer choose and implement electronic QMS when needed
  • Helping the manufacturer maintain and continually improve their QMS
  • Support the manufacturer with daily QMS activities including nonconformances, feedback, complaints, internal and supplier audits, vigilance, and many others
  • Offering customized and open training for medical device QMS
Meeri Säily

Contact us for more information

user
Meeri Säily
Sales Manager
contact-email
meeri.saily@labquality.com

Leave a contact request

Related Services

Quality Management System ISO 13485
QMS
Auditing services

Quality Management System ISO 13485

Labquality provides medical device manufacturers help with setting up quality management systems (QMS).

Read more
QMS Improvement and Gap Analysis
QMS

QMS Improvement and Gap Analysis

Labquality can help medical device manufacturers continually improve their quality management system (QMS).

Read more

Latest news

20/09/23 12:09

Meet us at BCLF 2023

Labquality’s international sales team will be available for meetings at the XXX Meeting of the Balkan Clinical Laboratory Federation on 27-30 September 2023 in Montenegro.
Read more
06/09/23 09:00

Data management in clinical investigations - Part 4: Statistical considerations for pivotal investigations

Medical device manufacturers planning their first pivotal premarket investigations for CE-marking benefit greatly from early collaboration with statistics professionals and an understanding of statistical principles. We offer data management, biostatistics and data protection services as part of the wider CRO clinical investigations offering.
Read more
05/09/23 07:19

Meet us at ECP in Dublin!

Labquality will be attending the 35th European Congress of Pathology on 9-13 September in Dublin.
Read more
01/09/23 12:30

Welcome to Labquality Days 2024!

The scientific program for Labquality Days 2024 has been launched and registration is now open!
Read more
30/06/23 15:02

New pilot studies announced!

We have four EQA pilot studies coming up after the summer holidays! The arranged pilots will be free of charge for a limited number of participants.
Read more

Subscribe to our newsletter

Subscribe to hear the latest news in the industry and keep track of what's happening behind the scenes.