GE Healthcare
Life Sciences

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  • Services
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Quality management

Quality Management
  • Bioprocess Regulatory Statements
  • Extractables information
  • FAQ
  • Quality Management
  • Regulatory Support

Documents

  • Quality policy
  • ISO 9001:2015
  • ISO 22301:2012
  • ISO 13485:2016 Eysins
  • ISO 13485:2016 Uppsala (Ficoll-Paque PREMIUM)
  • Quality management system
  • Standard for GE Healthcare Life Sciences Change Control Process for Designated Products.

Declaration of conformity and EC Certificate (Eysins site)

  • Medical devices:
    • EC Certificate, Directive 93/42/EEC on Medical Devices, Biosafe S.A
    • Declaration of Conformity Disposable cell separation kits CS-XXX.X and accessories
    • Declaration of Conformity FA-100.2
    • Declaration of Conformity FB-100.x and accessories
    • Declaration of Conformity Sepax 2
    • Declaration of Conformity Sepax 2 RM
    • Declaration of Conformity Smart-Max AS-310
    • Declaration of Conformity RCP-100
  • Laboratory equipment:
    • Declaration of Conformity Sefia Cell Processing Kit
    • Declaration of Conformity Sefia Instrument
    • Declaration of Conformity Sepax C-Pro
    • Declaration of Conformity Sepax C-Pro Kit and Sampling Line

We know quality

Many companies test for quality. At GE Healthcare, quality is simply ingrained into who we are. Throughout the design and manufacturing process, every aspect of your GE Healthcare product must meet stringent quality requirements and achieve a high level of performance.

GE Healthcare’s Life Sciences business has more than 50 years of experience in the biotechnology industry. We offer a wide range of technologies, products, services, and knowledge as well as regulatory support documentation for products used in regulated environments. Our track record of continued supply to the biopharmaceutical industry shows our commitment and capability.

To request a customer audit, contact your local GE representative.

  • EHS program management
  • Sustainability

Environmental, health, and safety (EHS) program management

GE is committed to having a world-class program for managing environmental, health, and safety (EHS) risks. The commitment begins with our Board of Directors, which regularly reviews the company’s environmental and safety performance. GE’s vice president for EHS sets the global EHS policy and implements the EHS strategy.

Read more about the EHS program.
GE Healthcare EHS Policy


At GE, sustainability means aligning our business strategy to meet social needs, while minimizing environmental impact and advancing social development.

As our business has globalized, so has our supply chain, including locations where environment, health, safety, labour, human rights, and other practices can be problematic. We expect our suppliers to obey the laws that require them to treat workers fairly, provide a safe and healthy work environment, and protect environmental quality.

Read more about our sustainability work.

Learn more

  • BioProcess chromatography resins
  • BioProcess equipment (downstream) and software

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