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IMPLEMENTATION OF THE QUALITY MANAGEMENT SYSTEM
(BIOBANKS)

We offer advisory and consulting services for compliance with international standards in the field of medical devices and biotechnology. We help in the implementation of procedures according to harmonized reference standards for different medical devices.

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Quality Management

ISO 13485 Medical devices. Quality Management Systems. Requirements for regulatory purposes.
ISO 9001 Quality Management Systems. Requirements
ISO 15189 Medical laboratories. Requirements for quality and competence.
ISO 20387 Biotechnology. Biobanks. General requirements for biobanks.

Medical Devices

ISO 62304 Medical device software. Software life cycle processes.
ISO 14971 Medical devices/medical products (MD). Application of risk management to MDs
ISO 15223-1 Medical products. Symbols to be used with the information to be supplied by the manufacturer. In vitro diagnostic medical products.
ISO 23640 Evaluation of stability of in vitro diagnostic reagents

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IMPLEMENTATION OF THE QUALITY MANAGEMENT SYSTEM
(BIOBANKS)

Quality Management

Medical Devices

300K is Passion Involvement Commitment Effort Perseverance Resilience Excellence Innovation

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IMPLEMENTATION OF THE QUALITY MANAGEMENT SYSTEM (BIOBANKS)

Quality Management

Medical Devices

300K is Passion Involvement Commitment Effort Perseverance Resilience Excellence Innovation

Menu

Privacy Policy

Cookies Policy

IMPLEMENTATION OF THE QUALITY MANAGEMENT SYSTEM
(BIOBANKS)