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 IVD Directive 98/79/EC 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.

We use certified, qualified management to oversee the regulatory processes that we undergo throughout development and manufacturing, as well as established complaint handling, change control, and proven risk management. 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

Your Project is Our Business.