ISO 13485:2016

Medical Devices - Quality Management Systems

What's ISO 13485:2016?

It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.
In addition, the standard can be used by supply chain organizations that are required by contract to conform. ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.

Why is ISO 13485:2016 important for your organization?

These days, medical device manufacturers often insist that their suppliers and service providers are certified to ISO 13485 as a pre-requisite for doing business. ISO 13485 certification is, therefore, an increasingly important differentiator for organizations looking to improve their marketability.

Whilst the primary objective of ISO 13485 certification is to facilitate harmonized QMS requirements for regulatory purposes within the medical device sector, companies also value ISO 13485 certification for the increased confidence that it gives patients and other stakeholders through its implicit promise of quality, consistency, and continual improvement.

How can we help you in regards to ISO 13485?

Whether you are looking to get certified against a globally recognized medical device QMS, or if it is towards compliance with the Medical Device Directive (MDD) 93/42/EEC or In Vitro Diagnostic Device Directive (IVDD) 98/79/EC, we provide a range of services including:

  • Gap analysis
  • Documentation against ISO 13485
  • Support for implementation in order to get international certification

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