Quality assurance

ISO 13485 is the standard for a Quality Management System, QMS,  for the Design and Manufacturing of Medical Devices, and it is intended to help Manufacturers (and others) to ensure the quality and safety of launched devicec.

The QMS describes the documents, procedures, and responsibilities required by the Manufacturer to ensure quality and safety of finished products. It ensures that every time a process is performed, the same methods, skills, information and controls are used and applied. The consultants at Orderly People have solid expertise regarding several Regulatory Requirements and different Standards, such as ISO 13485, ISO 14971, MDR, IVD/IVDR and FDA 21 CFR Part 820. We can assist in implementing, developing and maintaining an ISO 13485 QMS that suits your needs.

In addition to that, Orderly People also supports you with:

• Gap-analysis towards ISO 13485, MDR, IVD/IVDR and FDA 21 CFR Part 820 and MDSAP 

• Implementing a QMS according to your company's specific requirements

• Conduct QMS Internal Audits

• Conduct Audits of subcontractors