The primary goal in the design and manufacture of a medical device is to produce a quality product that meets the applicable requirements and specifications for its intended use. Such a product provides assurance that the medical device can be consistently manufactured and will perform as planned, safely and effectively. This can be achieved through the implementation of a quality system.1

What do quality system requirements cover?

Medical device manufacturers who plan to take their product to the global marketplace should carefully review the ISO 13485 Medical Devices Quality management systems requirements for regulatory purposes and the US Code of Federal Regulations (CFR) Title 21, Part 820 Quality System Regulations(QSR).2,3 These requirements define the quality system standards for medical device design and manufacturing―good manufacturing practices for medical devices.

These quality system requirements (as per QSR) cover a wide range of topics1,2 such as:

  • Management and organization
  • Design
  • Document controls
  • Purchasing controls
  • Identification and traceability
  • Production and process controls
  • Acceptance activity (in relation to inspections, tests and verification activities)
  • Non-conforming products
  • Corrective and preventive actions
  • Labelling and packaging control
  • Handling, storage, distribution and installation
  • Records
  • Servicing
  • Statistical techniques
  • Inspections

Due to the broad variety of current and conceivable medical devices, the ISO 13485 standard and the US QSR do not stipulate how a manufacturer must produce a specific device. Rather, they ensure product quality by providing a framework that requires manufacturers to develop and follow written procedures specific to their medical devices.4 In other words, the manufacturer should establish methods and procedures to address the applicable quality system requirements related to the design, manufacture and distribution of their devices. Depending on the type of medical device or your organization, these requirements and standards may represent only a minimum baseline for designing and producing your medical device. Manufacturers may implement additional requirements or more sophisticated quality programs to meet the needs of their operations and the needs of their customers.

It is critical to understand that the ultimate responsibility for meeting these requirements resides with the manufacturer, even if some of the activities are delegated to a third party (for example, a contract manufacturing organization).4

Quality system requirements: Canada, the US and the EU

The specific quality system requirements for Canada, the US and the EU are summarized in Table 1.

Table 1: Quality system requirements for Canada, the US and the EU

Country Requirements<
Canada
  • Mandatory for class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under ISO 13485:2003.*
  • No regulatory quality system requirements apply for class I medical devices.5
US
  • Mandatory for class II, III, and select class I devices (for example, class I devices automated by software).
  • Devices exempt from Good Manufacturing Practices (GMP) are codified in 21 CFR 862 to 892.
  • Exemption from GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).4
EU
  • Device manufacturers have several options in obtaining CE marking via different conformity assessment routes (for example, having their devices tested or having a quality system).
  • With the quality system route, compliance with ISO 13485 is voluntary and a company can choose to use other systems that are equivalent. However, it is important to keep in mind that Notified Bodies** prefer to have a well-understood system when auditing.6

*Standards are updated periodically. It is important to ensure that the version followed is recognized by corresponding markets.

**A Notified Body is certification organization that the national authority of an EU Member State designates to carry out one or more of the conformity assessment procedures described in the annex(es) of the EU Directives. It must be qualified to perform all the functions set out in any annex for which it is designated.7

Assuring medical devices are of the highest quality

There are many way in which a manufacturer can provide greater assurance that their medical device is of the highest quality. These include:1

  • Developing an effective design control plan
  • Conducting risk analyses
  • Following adequate and appropriate standard operating procedures and protocols for testing
  • Using validated methods and procedures
  • Monitoring and auditing clinical trials
  • Establishing and implementing a company quality policy
  • Ensuring adequate staff training
  • Conducting quality audits
  • Implementing a quality control program
  • Maintaining, analyzing and following up on complaint files
  • Adopting and implementing appropriate corrective and preventive action plans

 

Disclaimer

The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.

Published: October 17, 2012

References

  1. DeMarco, C.T. Chapter 7. Quality System and GMPs. In Medical Device Design and Regulation. (2011). Milwaukee, WI: ASQ Quality Press.
  2. United States Code. (2012, April). Title 21. Part 820, Quality System Regulation. Retrieved October 3, 2012, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820.
  3. ISO 13485:2003. Medical devices―Quality management systems―Requirements for regulatory purposes.
  4. U.S. Food and Drug Administration. (2011, April 28). Quality System (QS) Regulation/Medical Device Good Manufacturing Practices. Retrieved June 4, 2012, from http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/default.htm.
  5. Health Canada. (2011, December 7). Quality systems ISO 13485. Retrieved June 4, 2012, from http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/index-eng.php.
  6. Industry Canada. (2010). Quality system requirements for medical devices. Retrieved June 4, 2012, from http://publications.gc.ca/collections/collection_2011/ic/Iu44-23-2010-eng.pdf.
  7. The Medicines and Healthcare products Regulatory Agency. (2006, January). The Notified Body: Bulletin No. 6. Retrieved September 25, 2012, from .