ISO certification and FDA registration are important watchwords when it comes to the manufacture of medical devices. But why? What do these accreditations mean? We’ve created a primer to help you understand the importance of these regulatory bodies and how their seal of approval ensures your medical device manufacturer provides unparalleled levels of service, quality, and assurance.

ISO 13485 Certification for Medical Device Manufacture

Why is ISO important?

ISO 13485 is a standard that helps companies maintain medical-grade quality, satisfy customer needs, and achieve continual improvement. This complex certification is considered integral to qualifying for international markets and as such is incredibly valuable to clients looking to grow their market. Specifically designed for medical device manufacture, this certification ensures;

Market-specific requirements such as the FDA’s 21 CFR 820 and the European Union’s Medical Device Regulation (EU) 2017/745, which has replaced the Medical Device Directive 93/42/EEC, are met and exceeded by everyday business practices. These include;

• High standards in the workplace to ensure product manufacturing safety and integrity
• Extra insight and focus on potential risks during the product development process
• Improved inspection and traceability measures for all medical devices
• Specialised processes for sterile medical devices
• Strict adherence to cleanliness requirements

This trusted mark of quality is maintained by the ISO. The ISO (International Organization for Standardization) is an independent organisation with a membership of 167 national standards bodies across the globe. Headquartered in Switzerland, its goal is to ‘support innovation and provide solutions to global challenges’.

To do this; their members and experts develop market-relevant, consensus-based standards. At Europlaz, we are proud to offer ISO 13485 certified medical manufacturing services and are committed to ensuring that all our products and services meet strict ISO standards. In doing so, we continually look for ways to reduce risk, improve production efficiency, product quality, and performance.

FDA Registration

Why is the FDA Important?

The FDA (The U.S. Food & Drug Administration) is a governing body responsible for protecting public health in the USA. To do this; they audit and investigate company practices to ensure; ‘the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.’

The FDA tests and categorises medical devices into different classes (Class III, Class II and Class I). For classes specific to medical devices the FDA break down requirements into;

• Class III – Complex medical devices that are implanted in your body, life-sustaining, or have the potential to cause significant injury or illness in the body

• Class II and I – Lower-risk devices and products used outside of the body, like motorised wheelchairs and catheters, fall into Class II and Class I

In providing this oversight, the FDA protects American consumers and ensures products sold in the US meet stringent safety standards. At Europlaz we are pleased to be FDA registered and carry out all work to a high standard. For more information on our services please feel free to contact our team and discuss your needs.

Europlaz Medical Device Manufacturing: ISO 13485 certified and FDA registered

At Europlaz we are pleased to be both ISO certified and FDA registered. Our ISO 13485 certification is core to the Europlaz Quality Management System (QMS) and allows us to measure our high medical device quality assurance standards to the norm and ensure we always provide clients with market-leading medical device manufacturing.

Along with ISO 13485, the Europlaz QMS also adheres to the European Medical Device Directive 93/42/EEC, as well as the FDA 21 CFR part 820 Quality System Regulations for medical devices.

The FDA has issued a proposed rule to amend the device Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. This proposal has been put forward to further ease international trade without compromising standards.

At Europlaz we are proud to have a QMS that maintains ISO 13485 and FDA standards allowing us to manufacture a wide range of contract medical devices for clients in the UK, US, Europe and across the world.

The benefits of working with an ISO certified and FDA registered medical manufacturer

What do all these accreditations mean in the real world? Trust, compliance, and versatility.

Trust

Trust is an integral part of medical device manufacture. Whether a complete design and manufacturing process or a simple packaging or testing project, our commitment to regulations gives you;

• Efficient product design, manufacture, and delivery
• Fewer errors and reduced costs/waste as a result
• Improved performance and reduced costs
• More trust within your industry

This trust in your product or service is key to winning new business and maintaining good relations with existing companies.

Compliance

Along with your clients’ trust, a commitment to working with an ISO 13485 certified or FDA registered manufacturer means compliance with governing bodies. Compliance is a great way to open the door to new markets and ensure you meet the criteria needed for specific industries or locations.

Versatility

Last, but not least, by working with a compliant medical device manufacturer such as Europlaz, you have the versatility to tailor your product for a variety of markets. Our highly experienced teams have a thorough understanding of the medical device manufacturing processes. They are flexible, resourceful, and capable of handling projects of all shapes and sizes. Whether you are an SME, start-up or an international blue chip medical device supplier; there is no substitute for working with an ISO certified or FDA registered medical device manufacturer.

Medical Device Manufacturing certified to ISO and aligned with FDA standards

With over 40 years of experience, we have extensive knowledge and insight into the medical device design and manufacturing process. We have worked on a variety of projects including medical diagnosis, device, and pharmaceutical applications and pride ourselves on completing projects to ISO 13485, FDA, and client’s standards. This commitment to quality has allowed us to expand our operation and gain experience in a wide array of biomedical device design, development, and manufacturing. If you’re interested in finding out more about ISO 13485, EU Medical Device Regulation or FDA 21 CFR part 820 Quality System Regulations contact us now. We look forward to assisting you on your next medical device project.