- ISO 13485 certification
- Easy to use ISO 13485 QMS
- Increased market access
- MHRA device registration
Medical Device ISO 13485 Quality Systems Consultancy
ISO 13485:2016 is the international quality management standard for medical devices.
Class IIa, IIb, and III Medical device manufacturers who sell products within the UK and EU must apply controls as part of a formal ISO 13485 quality management system. Class I medical devices are associated with the lowest level of risk while class III medical devices are associated with the highest level of risk. ISO 13485 certification provides interested party confidence and assurance of medical device quality.
Conformity with and ultimately certification against ISO 13485:2016 includes the effective implementation of quality procedures and records including technical files. These must be sufficiently comprehensive and robust then evidenced to your ISO assessor for conformity to ISO 13485 and applicable device related regulatory requirements.
If your organization is committed to ISO 13485 implementation you might be consider engaging a consultant to assist with the implementation process.
DAT Performance frequently assists organizations like yours to build a first class medical device quality system that always result in ISO 13485 certification and improved performance. Whether you are starting from ground zero with nothing in place or at the point from where your system requires refining and preparing for certification we can help!
DAT possess the consultants and tools required to get the job done, including our cost effective ISO management software, ProActive. Combined with the enthusiasm of your team our services help to provide improved recognition for both your organization and its medical devices.
ISO 13485 certification benefits include:
- Access to new markets
- MHRA compliance and registration
- Certification to an internationally recognised quality standard
- Competitive advantage
- Conformity to regulatory requirements
- Technical file conformity UKCA and CE product marking
- Improved processes
- Reduced levels of process risk
- Technical excellence
- Repeat business
ISO 13485 consultancy and ProActive ISO compliance software
- Click the VISIT PROACTIVEQMS button to access ISO 13485 compliance software offers
- Scroll down to request your ISO 13485 consultancy quote