Quality Management

Invitek Molecular always strives to be a reliable partner for our diverse customers of the IVD industry as well as biotech start-ups and research institutes worldwide. For the first time Invitek was certified in 2005 according to international standards for a quality management system.

We produce our products and services in accordance with EN ISO 13485:2016 and in compliance with the applicable regulatory requirements of the European REGULATION (EU) 2017/746 for in vitro diagnostic medical devices. Our quality system is designed to meet stringent regulatory requirements, but flexible enough for us to customize any specific items for your needs.

Regular monitoring of our ISO 13485 certification ensures adherence to prescribed controlled processes throughout development and manufacturing, as well as proven risk management, change control, and established complaints handling. State-of-the-art processes and systems provide comprehensive documentation that enables smooth release in all relevant markets. You can have confidence in our ability to manufacture products and assay components reproducibly and to provide the required quality documentation.

These requirements include

Detailed manufacture and QC documentation

Production and process controls

Product Certificates

Traceable system-controlled product batch records

Product stability programs

Controlled temperature monitoring program

Product change control and notification procedures

Supplier evaluation and qualification program

Equipment maintenance and calibration program

Nonconforming product and complaint-handling procedures

Design control

Clear and transparent guidelines and procedures for the implementation of the requirements for medical devices

Qualified, educated and trained personnel

Post-market surveillance

Our expertise for your sample