Glossary for Medical Device Companies
Medical Device Development Industry Terms
When diving into a new field it’s important to have as many information as possible at one place. For that reason we’ve created this medical device development glossary. If you’ll have additional questions, please don’t hesitate to contact us.
Your company’s products are subject to clinical trials and approval processes with regulatory bodies in Europe, Asia, USA and the rest of the world.
The European Medical Device Regulation (EU MDR) is the regulation applicable to all medical devices that are targeted to the EU market from 26 May 2021 onwards.
ISO 13485:2016 specifies the requirements for a quality management system that can be applied in the different phases of the life-cycle of a medical device.
ISO 14971 is a standard for the application of risk management to medical devices to determine the safety of a medical device during the product life cycle.
IEC 60601-1 helps manufacturers to ensure that a medical device complies with the basic safety & essential performance requirements for medical electrical equipment.
IEC 62304 is a standard that defines the life cycle requirements for software that is used in a medical device.
Medical device classification is a system of controlling whether a medical device conforms to regulatory framework demands.
A Medical Device Company is a commercial organisation that develops medical devices, medical software, medical accessories and surgical instruments.
Medical device engineering (MDE) is a set of activities that employ engineering concepts to create a useful and safe medical device for patients.
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Collecting requirements. Designing initial architecture. Creating a cost model. Prototyping. Testing. Assuring quality. Designing for manufacture.
You must carefully plan and oversee the development of your medical device. A set of product development guidelines should be prepared early on in the development.
The medical device product development life cycle are the successive planned stages or phases in a manufactured product’s life, from the very start to the end.
There are many standards that help manufacturers to comply with regulations that apply to medical devices. Learn about ISO 13485, ISO 14971, and others.
Notified bodies perform conformity assessment procedures laid out in the EU directives or regulations that are applicable to medical devices.
QMS is a structured system of processes & procedures for managing many facets of the development process.
Software as a Medical Device (SaMD) represents software that can execute at least one medical function.
Unique Device Identification is a series of alphanumeric characters that is created through a globally accepted device identification and coding standard.
SOUP describes software included in medical devices or in medical software that was not developed according to a known software development process.
