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ISO 13485: 2016 Consultancy

For all medical device manufacturers marketing and selling their products within the EU, the controls for the product lifecycle must be found within a documented quality management system. For all class IIa, IIb and III devices produced under a full quality assurance system must be in accordance to ISO 13485, the current state of the art in medical device quality management system standards.

ISO 13485 is not only a quality system standard but one for which the whole organisation is required to engage, touching upon almost every aspect of the business operation. For all those wishing to comply with the standard getting started and understanding the best way of making the standard work for you can be daunting.

The general requirements for compliance to the standard include many different procedures and record types in order to be certified, all of which must be reviewed, approved, maintained and updated to remain in compliance.

Here at Advena we can help build these processes and documents whether starting from scratch or if requiring upgrade to meet your organisational needs and objectives.

The benefits of the implementation include:

  • Increased access to worldwide markets.
  • Increased organisational efficiency.
  • Increased competence and industry awareness.
  • Adopt a systematic approach to meeting the regulations as well as customer expectations.

Tailoring the system to your needs allows additional efficiency, quality and reliability for your product and for your company.

Advena specialise in the creation, installation and day-to-day monitoring of medical device quality management systems for all manufacturing and related services to ensure full compliance to the ISO 13485 standard.

In addition, Advena can create paper systems, electronic systems, or even web-based systems (ACTIV) which may be accessed from anywhere in the world and can be tailored to your organisational structure and requirements.

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