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.
Detailed manufacture and QC documentation
Production and process controls
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
Clear and transparent guidelines and procedures for the implementation of the requirements for medical devices
Qualified, educated and trained personnel