INTERNATIONAL STANDARDS

As a manufacturer of medical devices it is our goal to sell the IVD rapid test developed and produced by us worldwide. By means of ISO 13485 we have achieved the possibility to comply with the Food and Drug Administration Quality System Regulation (QSR).

The FDA QSR (21 CFR Part 820), for example, requires us as a manufacturer to use a quality system for the design, manufacture, packaging, labelling, storage and delivery of medical devices. This requirement is also generally known as Good Manufacturing Practice (cGMP or GMP).

We are working to extend our existing ISO 13485 quality management system to include GMP requirements. The extension will ensure that all requirements of the European CE marking, the Canadian Medical Devices Regulations and the Japanese Ordinance #169 can be met.

QM SYSTEM ISO 13485

PharmACT is a manufacturer of medical devices using the ISO 13485 quality assurance system. The QM system is based on ISO 9001, but takes into account the special requirements for manufacturers of medical devices and in-vitro diagnostics (IVD). Our current certification according to ISO 13485 was completed in 2019. We meet the legal requirements for medical devices and the in-vitro diagnostics directive.

UDI – Marking for IVD

Unique Device Identification (UDI) is a legal requirement for the worldwide unique and machine-readable labelling of medical devices and in-vitro diagnostics. It applies to Europe and the USA.

Our products have a unique device Identifier (DI), which consists of the lot number (LOT), the expiry date and our PNN (Pharmacy Product Number).