Quality and Regulatory

Gener8 is certified to both ISO 9001: 2015 and ISO 13485: 2016

We are licensed medical device manufacturers by the FDA. Our software is developed against IEC 62304 standards.

V&V

Our design control system assures evaluation of the design and assembly processes while assessing risk early in the design process, thereby providing a seamless hand-off to the manufacturing side of our business.

For medical clients, we have a dedicated group skilled in the deliverables to meet our ISO 13485 requirements.

Our software division employs a separate group of verification and validation employees to ensure success.

UL/CE Certification

Throughout development, we design to reduce the risk of EMI exposure and safety concerns. We work with contracted services for EMI and Safety testing to comply with CE and UL certification requirements and to ensure compliance with IEC 60601 and IEC 61010.

We have a test chamber for pre-scans for UL/CE certifications. Gener8 works with testing agencies such as TUV, ELT, and CSA. We have environmental chambers in house and a BSL II lab for blood and chemistry testing in-house

Regulatory Conformance

Throughout development, we design to reduce the risk of EMI exposure and safety concerns. We work with contracted services for EMI and Safety testing to comply with CE and UL certification requirements and to ensure compliance with IEC 60601 and IEC 61010.

We have a test chamber for pre-scans for UL/CE certifications. Gener8 works with testing agencies such as TUV, ELT, and CSA. We have environmental chambers in-house and a BSL II lab for blood and chemistry testing in-house

Thousands of projects completed.

We’re proud to serve the Biotech, Medical, and Industrial markets.

Instruments & Devices
1,650+
Microfluidic Cartridges & Consumables
500+
Clients
400+