Quality

100% quality focused

Built-in quality from design to commercial manufacturing

Nemera’s industrial teams share a belief that the devices they manufacture have an impact on patients’ health. That is why quality is so critical to them.
Every month, we assess Nemera’s four industrial sites’ capacity to deliver on time and accurately the world over, to keep operators safe from even minor incidents, and to satisfy customers and patients.

Quality is the key driver in our organization
to ensure that patients will receive the best product and service possible

  • One harmonized development process
  • Process validation
  • Training and mindset
  • Regulatory support
  • In-house laboratory capabilities
  • Quality by design
  • Usability engineering
  • Design transfer
  • Regulatory support
  • Risk Management

Certified management system

ISO 13485

Medical Devices

ISO 15378

Primary packaging

ISO 14644

Cleanliness

ISO 14001

Environmental

ISO 50001

Energy management

Full turnkey solution with Drug Handling​

Pharmaceutical drug manufacturing certification for primary packaged pharmaceutical drugs and medicinal products: license for cartridge-based autoinjectors manufacturing & assembly, granted in 2017 to Neuenburg facility (GER).

  • Handle
  • Assemble
  • Sterilize
  • Store
Quality, Drug manufacturing authorization for autoinjectors

Patient safety and satisfaction are directly associated with the quality we deliver to our customers within our products, services and communications. Quality is a result of highly capable processes and efficient systems.
Based on risk assessments, we are focusing early on to design capability into our processes in order to minimize process variation
and avoid deviations. Regular trending of our processes along with selected product controls are applied to confirm product conformance and performance, unit by unit.

Christian MEUSINGER, VP Quality, Regulatory and Compliance

1
employees
1
plants in Europe and in the USA
1
sqm clean room manufacturing
100 %
QUALITY