Invotec GmbH offers equipment validation as part of companies’ process validation
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.
Waldorf Technik GmbH, a sister company of Invotec within the HAHN Group, will also be at Pharmapack Europe. Waldorf Technik is also active in both the medical technology and healthcare industries. At the fair, they will highlight the Vario TIP® system—the patented, worldwide leading system concept for manufacturing pipette tips and blood reagent containers. The system ensures maximum productivity and increased patient safety. In addition to 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.
Invotec designs and builds custom assembly, test, and inspection equipment for medical device manufacturers. The company has three production sites in Villingen-Schwenningen, Germany, in Miamisburg, Ohio, USA, and in Brooklyn Park, Minnesota, USA. Invotec specializes in applications with small-to-medium-sized components and complicated assembly processes — providing a range of robust, reliable, semi-automated and fully-automated solutions. Invotec’s flexible approach allows customers to refine their product design while Invotec engineers the equipment. As part of the HAHN Group’s Assembly & Test Division since 2017, Invotec is able to leverage a network of best practices and global support. For more information visit www.invotec.com.
About Waldorf Technik GmbH
Waldorf Technik is specialized in automation for injection molding processes in the medical and packaging industries. The company currently employs approximately 100 staff in Engen, Germany. Based on more than 30 years of experience, automation from Waldorf Technik excels with cycle times between 2 – 20 seconds and a high number of cavities. Since 2016 the company is also part of the HAHN Group’s Material Handling Division. For more information visit www.waldorf-technik.de/en.
About HAHN Group GmbH
The HAHN Group consists of a network of specialized companies for industrial automation and robot solutions. With its own production sites the group currently employs approx. 1,400 staff at 27 locations. Well-known customers from the automotive, consumer goods, electronics, medical technology, and healthcare industries benefit from the HAHN Group’s 30 years of expertise and automation know-how. For more information visit www.hahn.group/en.
Press contact: Cordula Knüppel | phone: +49 162 10 45 056| email@example.com
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