Quality Management
The quality of the products and the optimal processes are a top priority at MediPac® GmbH. This is a part of our company philosophy.
The modern production and sterilization are subject to strict and regular validations as well as external and internal quality controls. The certifications prove the successful and qualified working method of the company according to current and international standards:
ISO 9001
Quality Management Systems – Requirements
This national and international standard specifies the minimum requirements for a quality management system.
It is the most important and most widely used standard in quality management worldwide. According to its specifications and requirements, companies and organizations of all sizes and in all industries can be certified.
The process-oriented approach of ISO 9001 calls for continuous improvements, which then show optimization possibilities in a company.
ISO 13485
Medical Products – Quality Management Systems –
Requirements for Regulatory Purposes
This industry-specific national and international standard is based on the structure and content of ISO 9001.
However, it places its core claim on the product safety of medical products. It is a prerequisite for the placing on the market of medical devices. Certification to ISO 13485 is mandatory for medical product manufacturers.
ISO 15378
Primary Packaging for Medicinal Products – Quality Management System – Good Managing Practices (GMP)
This industry-specific national and international standard specifies the requirements for a quality management system for the production of primary packaging for medicinal products, using Good Manufacturing Practice (GMP). Compared to ISO 13485, this closes a regulatory gap between medical product and pharmaceutical manufacturers. The application of GMP rules is mandatory for the pharmaceutical industry. ISO 15378 certification is a building block for the further development of our pharmaceutical primary packaging and accessories product groups. It enables us to better meet the requirements of the pharmaceutical industry.
Notified Body Confirmation Letter
This letter from our new notified body TÜV NORD CERT GmbH confirms that the MediPac GmbH products listed therein (Table 1) are in the process of being authorised by TÜV NORD CERT in accordance with the EU's MDR (Medical Device Regulation).
This means that they may be manufactured and placed on the market until the expiry of the extended deadline of the MDD for medical devices of risk classes IIa and IIb, i.e. until 31 December 2028.
MediPac GmbH products not listed in Annex 1 are also in the process of being authorised, but will be authorised from scratch as medical devices.
