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Quality

Quality is built into every process.

Our quality approach connects design intent, supplier control, manufacturing discipline, verification and traceability.

Medical-device quality inspection

One connected system

Evidence-led quality systems.

Nuvell combines documented processes, defined responsibilities, inspection, validation and continuous improvement to support consistent medical-device manufacturing.

Request quality information
01

Quality management

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

02

Supplier quality

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

03

Incoming inspection

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

04

In-process control

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

05

Testing & inspection

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

06

Process validation

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

07

Product validation

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

08

Traceability

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

09

Sterilization control

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

10

CAPA & improvement

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

11

Document control

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

12

Regulatory alignment

Defined responsibilities, controlled records and risk-based decisions support consistent execution.

Company credentials

Quality, regulatory and procurement credentials

13485
ISO 13485
9001
ISO 9001
MD-5
CDSCO MD-5
MD-9
CDSCO MD-9
GeM
Government e-Marketplace
ZED
ZED Gold

The marks shown are neutral website identifiers, not reproductions of official certification logos. Certification and licence scopes apply strictly as stated in the respective valid documents and do not imply approval of every product displayed on this website.