Quality management

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

Documents

  • Quality policy
  • ISO 9001:2015
  • ISO 9001:2015 Cambridge
  • ISO 13485:2016 Cambridge
  • ISO 22301:2019
  • MDSAP Certificate Eysins
  • ISO 13485:2016 Eysins
  • ISO 13485:2016 Intermountain
  • ISO 13485:2016 Logan
  • ISO 9001:2015 New Zealand
  • ISO 13485:2016 New Zealand
  • ISO 13485:2016 Pasching
  • ISO 9001:2015 Singapore
  • ISO 13485:2016 Singapore
  • ISO 13485:2016 Uppsala (Ficoll-Paque PREMIUM)
  • ISO:13485:2016 Dassel
  • ISO 13485:2016 Tonglu
  • ISO 14001:2015
  • Quality management system
  • Standard for Cytiva Change Control Process for Designated Products.
bp-service

Declaration of conformity and EC Certificate (Eysins site)

Please note that the below documents correspond to the last available version, and thus it will not apply to products manufactured before the issue date of the document

  • Medical devices:
    • EC Certificate, Directive 93/42/EEC on Medical Devices, Biosafe S.A
    • Declaration of Conformity Class 1 Accessories MDR
    • Declaration of Conformity FA-100.2
    • Declaration of Conformity FB-100.x
    • Declaration of Conformity RCA-100
    • Declaration of Conformity Sepax RM (Sepax 2 RM)
    • Declaration of Conformity Sepax S-100 (Sepax 2)
    • Declaration of Conformity Sepax disposable cell separation kits
    • Declaration of Conformity Smart-Max AS-310

We know quality

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

Cytiva’s 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 Cytiva representative.

  • EHS program management
  • Sustainability

Environmental, health, and safety (EHS) program management

Cytiva 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. Cytiva's vice president for EHS sets the global EHS policy and implements the EHS strategy.

Read more about the EHS program.
Cytiva EHS Policy
ISO 14001:2015 Certification


At Cytiva, 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