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MEDICAL DEVICE MANUFACTURING

Welcome to Hennig Enterprises Europe - a leading east european company specialised in medical device & parts contract manufacturing.

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Over 19 years of know-how and experience

Hennig Enterprises Europe is a medical device manufacturer, established in 1994 in Iasi, Romania. Our aim is to produce innovative medical devices that improve common medical procedures by providing customers with outsoucing services of the best quality at the most competitive prices.

The company has grown constantly ever since its inception. Today, it has 200 highly motivated employees, a building with a total area of over 1500 m² of production spaces, storage areas and offices, including two class 8 clean-rooms with a total surface of over 220 m².

Our over 19 years of experience in the medical device industry have made us very flexible and highly capable of finding the optimum solution for every customers specific needs. Also, thanks to the moderate labour cost in Romania, we can offer competitive prices compared to contract or private label manufacturers based in China or India.

  • Established in 1994
  • Located within EU
  • Over 200 well trained, highly skilled employees
  • Dedicated R&D department
  • 1500 m² facilities
  • 220 m² class 8 clean-rooms
  • Specialized in subcontracting services

High quality, defect free products delivered on time at unbeatable prices.

medical device production

SERVICES

We are able to provide a wide range of manufacturing services:

- injection moulding and extrusion capability (PE, PVC, PC, LSR, TPE, etc.)
- clean-room assembly operations
- gamma or ETO sterilization arrangements, monitoring and validation of special processes where required
- labelling/packaging of products (individually or in bulk)
- transport arrangements and control all the way to the final destination
- full logistic chain integration

We can either work with raw material supplied by the customer or make all the necessary arrangements ourselves. We can also undertake different other processes in a non-clean-room environment.

injection moulding
extrusion moulding
assembly
testing
sterilization
labeling / packaging
transportation
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High Quality Standards

We pride our uncompromised adherence to the highest standards of quality assurance, a culture of quality that demands that we do things right the first time, on-time, and every time while providing outstanding service and customer support.

The quality management system is periodically audited by regulatory authorities and our customers, as well as by us through our internal audit system and it is certified to be in compliance to the requirements of ISO 9001:2008 and ISO 13485:2003 standards, including CMDCAS.

Manufacturing is performed in a clean room environment (class 8, according to ISO 14644), according to GMP rules.

Flexible logistic packages: from injection moulding and extrusion of raw material into components to complex multi-part assembly, labelling, packaging, testing, sterilization and final delivery.

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DEDICATED R&D SUPPORT

We can assist our customers in developing and improving their products, thus considerably contributing to the products cost reduction. Our in house engineers are able to support any special project with customised solutions to each technological problem, thanks to our know-how and relationship with a large network of technical partners.

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CONSULTING

Are you still in product development stages? Thanks to our long history in the medical device industry we have access to a great network of experts that can assist you. Whether it's design, prototyping or production of small batches for testing purposes, please get in touch with us. We can help!

Our in house engineers are ready to assist you with customised solutions for any problem related to medical device design, manufacturing technologies or production logistics.

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CONTACT

SC HENNIG ENTERPRISES EUROPE SRL
14, blvd. Poitiers, Iasi, 700671, ROMANIA
T: +40.744.780470 | F: +40.232.224678 | E: contact@hennigenterprises.com



If you have any questions or comments, or if you would like to contact us for a quote, please use the form below and we will get back to you as soon as possible.