- ISO 13485 certification
- Easy to use ProActive ISO 13485 QMS
- Increased market access
- Increased efficiencies
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 confidence for interested parties in medical device quality conformity.
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 robust to provide confidence to your ISO assessor that the clauses of the quality management standard are being rigorously complied with by your business.
If your company has decided to implement ISO 13485:2016 you might be considering bringing in a consultant to assist with the implementation process.
DAT Performance can assist your company to build a first class medical device quality system that will both lead to 13485 ISO certification and added genuine value. Whether 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. These combined with the enthusiasm of your team help to place your business and customer recognition for its medical devices where it belongs.
ISO 13485 certification benefits include:
- Access to new markets
- Certification to an internationally recognised quality standard
- Creation of competitive advantage
- Conformity to regulatory requirements
- Technical file conformity and CE product marking
- Reduced levels of process risk
- Technical excellence
- Reduced waste