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The importance of quality assurance in disposable medical device manufacture

The importance of quality assurance in disposable medical device manufacture

Quality assurance is critical to all medical devices, including disposable ones. Should a manufacturer fail to provide quality assurance and a product does not function correctly, it could have increased risk to the end user. A failure to assure quality could also have severe ramifications for the product manufacturer.

Rules governing quality assurance in medical device manufacturing

The regulations that govern disposable medical devices depend on the market that the product is destined for. Compliance with these regulations is essential.

For example, if the product is destined for the European market, manufacturers must operate and products must be manufactured according to the international standards ISO 13485: 2016 (quality management systems for medical devices).

If the end market for products is the USA, the manufacturer must also be registered with the Food and Drug Administration, a federal agency of the United States Department of Health and Human Services, and follow the stipulations set out in the 21 CFR 820 regulation that covers quality systems for medical devices.

Other standards are linked to these core regulations and must also be adhered to, including those governing product cleanliness, the operation and control of cleanrooms, the control and validation of sterilisation, the control of calibration and the validation of packaging.

Quality assurance and the benefits of a medical device contract manufacturer

The process of assuring quality, for any medical device that is critical to patient health, requires strict compliance with the defined essential requirements, standards and regulations. To achieve this compliance, a wide range of specific skills, equipment and procedures must be practiced, used and followed. A contract manufacturer of disposable medical devices, such as Meridian Medical, has them all in place.

Quality assurance systems to look for in a medical device manufacturing partner

When it comes to what to look for in a contract manufacturer of disposable medical devices and quality assurance, you should choose a partner that manufactures a wide range of products in a variety of areas, such as IV management, drug delivery, urology, anaesthesia, paediatric and neonatal care, and general surgery. Such scale and scope mean that the company will have the resources and expertise to manufacture, test and inspect your product portfolio to the highest standards, however diverse it is and whatever components are required.

Your chosen medical device manufacturer should also have in place a full traceability framework, that stipulates the medical device manufacturing and supply process, detailing why, how, when and where a product was manufactured. A traceability framework provides supply chain visibility, improves quality control and reduces risk.

In terms of expertise, your contract manufacturer should be able to demonstrate that every relevant employee is taught about medical device visual quality standards and that a visual inspection is carried out at every stage of the manufacturing process by every person who is involved. In addition, there should be a range of other testing mechanisms in place, including those to check for leaks and blocks, and dimensional tests.

Furthermore, your medical device manufacturing partner should have an established quality assurance department that has a close relationship with the relevant client departments. This helps ensure quality requirements and that products meet and exceed expectations.

Medical device quality assurance and your contract manufacturing partner

The importance of quality assurance to a medical device manufacturer, and to medical staff and patients, cannot be understated. Partnering with a contract manufacturer with comprehensive quality assurance protocols and systems ensures that the highest standards of quality are always maintained and that your brand and reputation are fully protected.

Meridian Medical is an established and experienced contract medical equipment manufacturer, specialising in a wide range of medical device design, development and supply services.

To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or info@meridian-medical.com.

Published 09/07/2019


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