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.

EU-Directive 93/42/EEC

EU-Directive on Medical Products
EU Directive on Medical Devices

This European directive is the most important regulatory instrument for demonstrating the safety and medical-technical performance of medical products in the European Economic Area. It is also a prerequisite for the placing on the market of medical products. Only with a corresponding, valid EC certificate may medical devices listed in its annex be placed on the market.

Confirmation Letter

This letter from our new notified body TÜV NORD CERT GmbH confirms that the MediPac GmbH products listed therein (Table 2) are in the approval process at TÜV NORD CERT GmbH in accordance with the MDR (Medical Device Regulation) of the EU.
This means that they may be manufactured and placed on the market until the expiry of the extended deadline of the MDD.
Non-listed MediPac GmbH products are also in the approval process, but will be approved from scratch.

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