Process, Engineering & Manufacturing

Biomedical engineering is subject to the standard DIN EN ISO 13485:2016. This norm lays out the requirements for quality management systems covering medical device design, development, manufacture, installation and maintenance. Machinery used in medical device manufacturing must offer a high degree of precision and reliability. These requirements became even more demanding with the European Medical Devices Regulation (MDR). Medical device manufacturers must also pay attention to quality management for outsourced processes.

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Posts - that's to be discovered on the topic (101)

Product

SURGICAL INSTRUMENTS

Through many years of collaboration with companies operating in the field of surface treatments and finishes processes, we are able to supply a finished product, with the additional phases such as welding, polishing, anodizing, nickel plating, hardening, laser marking, tumbling and deburring.

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Product

Revolutionizing Healthcare with Advanced Medical Devices

Devomech Solutions is at the forefront of healthcare innovation, offering a range of high-end medical products that blend cutting-edge software, electronics, and mechanical engineering. Our commitment to improving patient care through technology is reflected in our diverse product lineup.

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Exclusive

Heads of the industry: A portrait of Bernd Block

Emotions, empathy and drive: Dr. Bernd Block is a global industry manager for medical technology at Trumpf Laser- und Systemtechnik AG in Ditzingen. His career is characterized by a multifaceted academic career. But for Block, his work is more than just a job - it is his passion.

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Service

GF Machining Solutions - Solution provider for production in the medical industry

Our solution for medical implants as well as for the medical mold & die industry include Milling, EDM, Laser, Software, Tooling and Automation, and Customer Services.

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Novelty

"Psilk-Cut" technology for medical applications

Discover our advanced "Psilk-Cut" slitting technology for your components. With the "Psilk-Cut" technology, we offer you innovative solutions for slitting your silicone components.

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Market & Industry

Rosti Poland Expands Medical Solutions Operations with Class 8 Cleanroom Investment

As part of Rosti Group’s growth strategy and continuous investment in our capabilities, we are delighted to open our new Class 8 Cleanroom facility at Rosti Poland.

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Interview

A global vision for medical injection moulding - Karl Stillman

Karl Stillman, Vice President, Strategic Sales, Rosti Group, explains to Medical Device Developments how technological capability and manufacturing knowhow must go hand in hand with management capability and years of experience to fully satisfy the industry’s requirements.

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Service

Medical subcontractor

Specializing in high-quality medical parts, we offer implants, instruments, and components for orthopedic and dental applications. Our products meet ISO 13485 and ISO 9001 standards, ensuring top-tier quality and safety.

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Product

Full electric molds for clean room

Over the last decade Pantostamp has developed and tested various full electric applications for its moulds. To operate in clean rooms and aseptic environments, Pantostamp produces its own molds using brushless engine complete with control units...

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Service

Medical Micro Molding

Medical micro molding is a highly specialized niche in the plastic injection molding industry. Medical devices from leading OEMs depend on micro-injection molded components as the miniaturize their technology, providing critical patient care in and outside the body.

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Providers (60)

ALLTEC Angewandte Laserlicht Technologie GmbH

FOBA Laser Marking + Engraving (brand of ALLTEC Angewandte Laserlicht Technologie GmbH) develops and supplies advanced laser technology for industrial direct part marking and engraving.

Selmsdorf, Germany

TRUMPF Laser- und Systemtechnik AG

With our laser systems, manufacturers of medical devices and medical components can process even the smallest components precisely, flexibly and sterilely. Find out how lasers are pushing the boundaries of what is possible in medical technology and ensuring gentler treatment procedures.

Ditzingen, Germany

Psilkon GmbH & Co. KG

Your specialist for everything around: SILICONE! We are a young, dynamic company that specialized in the production and development of silicone molded parts and assemblies.

Motten, Germany

Pantostamp Srl

Pantostamp is an Italian leading company in the market of injection mold manufacturing, founded in 1976 by Bernardo Scalici has consolidated its core business in the packaging sector, designing and manufacturing multi-cavity molds with a high technical quality content.

Opera 20073, Italy

Maider Medical Industry Equipment Co., Ltd.

As a market leader in the automation industry, Maider strives to provide its customers with advanced solutions for intelligent manufacturing. Maider oﬀers three categories of systems: Intelligent equipment, IO4-enabled data management and software, and Process development.

Yuhuan, Zhejiang, China

VC999 Verpackungssysteme AG VC999 Medical

VC999® Medical is a division of VC999 Verpackungssysteme AG based in Herisau, Switzerland. VC999® Medical offers a globally unique, complete packaging process with its own packaging validation for Tyvek, vacuumable PAPE and paper/film pouches.

Herisau, Switzerland

KinTat Rubber Technology Ltd

KinTat factory is located in a southern city called Jiangmen in the Guangdong-China area. At the first, we are certified with ISO9001, then ISO14001, later on ISO16949 for the company's automobile parts, and ISO13485 for medical silicone parts, Kintat also established a 100,000 Class Clean Room.

Kowloon, Hong Kong SAR China

MedtecLIVE

MedtecLIVE 2024 is the leading trade fair in Europe for the development and manufacture of medical technology

Nürnberg, Germany

ProByLas AG

ProByLas AG offers modular machines and machine components for laser welding of plastics. Ready-for-use "Turnkey" machines are offered and "Modula" machine components, which can be integrated into a special machine by a machine builder.

Root D4, Switzerland