Definition Of Product Family - Medical Devices

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Medical devices are assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

What constitutes a Medical Device Technical File "Family?"

https://elsmar.com/elsmarqualityforum/threads/what-constitutes-a-medical-device-technical-file-family.55794/

A group of medical devices can be considered as a "Family", if they have - - same intended use - belong to same class - share same design history file (DHF) - …

device group versus device category

https://www.johner-institute.com/articles/regulatory-affairs/and-more/device-group/

Definition: Medical device group “Group of medical devices manufactured by or for the same organization, and which have the same basic design and performance …

MDR - Article 2 - Definitions - Medical Device Regulation

https://www.medical-device-regulation.eu/2019/07/10/mdr-article-2-definitions/

(1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone …

HSA | Grouping medical devices as a Family

https://www.hsa.gov.sg/medical-devices/registration/grouping/family

Dec 1, 2019

Product Family Definition - Investopedia

https://www.investopedia.com/terms/p/product-family.asp

A product family is a collection of related products sold individually. A product bundle is a number of products packaged together at a special promotional …

medical device family Definition | Law Insider

https://www.lawinsider.com/dictionary/medical-device-family

Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means …

Fda Medical Device Manufacturer Definition - family-medical.net

https://www.family-medical.net/fda-medical-device-manufacturer-definition/

Medical devices (including diagnostic tests) are regulated by the FDA in the United States. All regulated medical products are monitored and maintained by the company. Medical …

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. A medical …