Villingen-Schwenningen, Germany – The new Invotec process offers support for companies to satisfy the new European Medical Device Regulation (EU-MDR).
Invotec is now offering a new equipment validation program to support medical device manufacturers facing implications from the new European Medical Device Regulation (EU-MDR).
Set to take effect this year, the EU-MDR will require medical device manufacturers to meet higher documentation requirements within a shorter reporting deadline—meaning many manufacturers are facing a significant increase in effort during the validation process. Invotec GmbH has developed over the past six months a standard process that provides customers with the best support. The integration of equipment validation into the project process eases the pressure of validation.
During the planning phase, Invotec works with the customer to create a customized project plan and define the necessary documentation to satisfy the EU-MDR. The following design phase builds on these definitions and works to minimize risks through controlled documentation of the development. Finally, in the testing phase, the functionality is verified and documentation for the performance of the equipment is provided.
Despite the streamlined process, customers can choose from flexible options throughout the process, ensuring that they have the necessary equipment information to meet their individual needs. Experts from the Invotec team in Villingen-Schwenningen, Germany will be available for interview at Pharmapack Europe 2020 on February 5 – 6 (Booth #B2) to explain the process, talk about latest advances in automation and discuss this program. The rollout of a similar program for US-based customers is planned for later this year.
Jointly with Invotec Waldorf Technik GmbH, a sister company of Invotec within the HAHN Group, will be at Pharmapack Europe. Waldorf Technik is also active in medical technology and the healthcare industries and highlights at the fair Waldorf Technik’s Vario TIP® system, which ensures maximum productivity, minimum space needed and increased patient safety. Vario TIP® is the patented, worldwide leading system concept for manufacturing pipette tips and blood reagent containers. Besides proven cycle times of up to 4.5 seconds and high cavity numbers of up to 128, the Vario TIP® Systems stand out with their extremely space-saving design and complete cavity sorting.