QMS
Das Qualitätsmanagementsystem Ihres Unternehmens muss sicherstellen, dass alle regulatorischen Anforderungen implementiert werden.
Für regulatorisch geforderten Verfahren oder Prozesse bieten wir fertige Lösungen an. Ob als komplettes Qualitätsmanagementsystem oder einzelne Elemente daraus, mit unseren Verfahrensanweisungen und Vorlagen stellen Sie sicher, dass Ihre Dokumente und Aufzeichnungen konform erstellt sind.
QMS Complete 5.0 (Basic package and options)
The regular services QMS Complete 5.0 can be implemented immediately or used as a reference system for your organization’s existing quality management system.
The regular services quality management system, QMS Complete 5.0, consists of a basic package and options.
The basic package contains a quality management manual and Standard Operating Procedures that all manufacturers of medical devices must implement. Depending on the product types or marketing areas, the basic package can be extended with optional Standard Operating Procedures (e.g. Standard Operating Procedures “Software development” or Standard Operating Procedures “Vigilance System USA”, “Biological Evaluation”, etc.). The basic package and the options then result in exactly the quality management system tailored to your company.
The regular services quality management system QMS Complete 5.0 covers the following regulations:
- ISO 13485:2016
- ISO 14971:2019
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- Directive 93/42/EEC
- Directive 90/385/EEC
- European QMS Guidelines (MDCG, MEDDEV)
- International QMS Guidelines (IMDRF, GHTF)
- US 21CFR820 (QSR)
- And much more.
The regular services QMS Complete 5.0 can be implemented once and then maintained at your own discretion. With our regular services QMS Complete 5.0 update service, you will receive regularly updated Standard Operating Procedures resulting from changing regulatory requirements.