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ISO 13485- Quality Management Systems for the Medical Device Industry


ISO 13485:2016 is an international standard for quality management systems in the medical device industry. It ensures that companies consistently meet customer and regulatory requirements for medical devices. The standard focuses on risk management, design control, process validation, and product tracking. It helps companies maintain compliance from product development to post-market monitoring, improving the quality, safety, and effectiveness of medical devices. This standard is essential for manufacturers, suppliers, and service providers in the medical device field.

What are the benefits of ISO13485:2016?

  • Regulatory Compliance: Helps ensure compliance with international regulatory requirements, facilitating market access globally.
  • Improved Quality: Enhances the quality of medical devices through stringent quality management practices.
  • Risk Management: Strengthens risk management processes, reducing the likelihood of product failures and recalls.
  • Customer Satisfaction: Increases customer trust and satisfaction by consistently delivering safe and effective medical devices.
  • Process Efficiency: Streamlines operations and improves process efficiency, leading to cost savings and reduced waste.
  • Competitive Advantage: Provides a competitive edge by demonstrating a commitment to quality and regulatory compliance.
  • Market Expansion: Facilitates entry into new markets by meeting the stringent requirements of various regulatory bodies.
  • Continuous Improvement: Encourages ongoing improvement in processes and products, driving innovation and excellence.
  • Enhanced Reputation: Builds a strong reputation for quality and reliability in the medical device industry.
  • Supplier Relationships: Improves relationships with suppliers and stakeholders by ensuring consistent quality and compliance throughout the supply chain.

At 3core2, we are accredited to provide certification for organisations involved in the transportation of medical equipment within the UK, as well as basic servicing, repair, and packing (non-primary kitting).


Transportation services include collecting products from manufacturers, wholesalers, or suppliers and delivering them to designated destinations. These destinations can include NHS hospitals, clinics, pharmacies, or direct delivery to other end users.

Servicing, Parts, and Packing (Kitting)

Organisations must document processes for receiving, repacking, and/or reassembling incoming goods into their final product. These items may be repackaged but do not require sterile environments to maintain product integrity. Components are picked and reassembled into a finished product, ready for delivery to distribution centres, retailers, or end users.

For example, this could involve collating individually sealed components of a lateral flow test kit—such as swabs, reagents, test strips, pipette stands, waste bags, and instruction leaflets—into a pre-printed box and bulk packing them into larger cartons.


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