Aug 29, 2014

A quality system is a necessary component of any medical device commercialization effort. For medical device manufacturers seeking regulatory clearance or approval in the US, 21 CFR Part 820 of US Code of Federal Regulations is necessary to meet quality system requirements (QSR) and bring their products to market.

In order to achieve FDA QSR compliance, you must implement a quality system covering the design, manufacture, packaging and labeling, storage and delivery of your medical device. Quality system requirements of 21 CFR Part 820 explain your obligations in the following areas:

  • Management responsibilities
  • Internal quality audits
  • Personnel qualification and training
  • Design controls
  • Document and purchasing controls
  • Identification and traceability
  • Production and process controls
  • Process validation

Policies for acceptance activities, nonconformance, corrective and preventative actions and distribution are also covered in FDA QSR.

FDA QSR quality system implementation and compliance typically takes five phases.

Phase I: Analysis and Planning

Phase I, Analysis and Planning, involves conducting GAP analysis of your existing quality assurance processes to determine strengths and weaknesses. Then, you would develop plans and schedules for FDA cGMP implementation and conduct firm-wide awareness training to ensure buy-in from all employees.

Phases II and III: Documentation Development and Implementation

Phases II and III entail Documentation Development and Implementation. During these phases of your FDA QSR quality system implementation, you’ll set your quality policy and objectives, and then write your quality system procedures, quality manual and other forms laying out your document control, design, development and other issues. You’ll also begin using your quality system procedures and develop records demonstrating 21 CFR Part 820 compliance.

Phases IV and V: Internal Auditing and Monitoring

Finally, Phases IV and V of the FDA QSR quality system implementation process deal with Internal Auditing and Monitoring. At this time you’ll conduct internal audits in order to assess the readiness of your FDA QSR quality system, and address any deficiencies or weaknesses based on your findings in order to establish full compliance.

Implementation Timelines

Implementation timelines for FDA QSR quality systems depend largely on the size and complexity of your manufacturing operations. For firms with fewer than 50 employees and a single manufacturing facility, quality system implementations can take three to six months. For manufacturers with more than 50 employees and multiple facilities, five to nine months may be necessary to complete implementation.


  • Stewart Eisenhart