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)
• U.v.m.

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.

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QMS Select 5.0

Individual Standard Operating Procedure from QMS Select 5.0 can be implemented immediately in your existing quality management system or used as a reference system for your organization's existing quality management system.

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QMS Tools

QMS tools are checklists of regulatory requirements that you can use to check the conformity of your QMS.

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QMS Special

A regular services QMS Special is a compilation of a standard operating procedure and accompanying technical information, such as a regular services feature publication, a regular services schematic diagram, regular services checklists and selected regular services Edu-Casts (training videos). QMS Specials are an excellent way to better understand a process and to train affected staff accordingly.

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Are you interested in our offer?

If you have compiled all the desired contents of this service, then contact us for a non-binding and free offer. We look forward to hearing from you.