Medical Device Manufacturing

INDUSTRY PERSPECTIVES

Trust But Verify: Validating AI In Pharma's GxP World

Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

Considerations For Rapid Prototyping In Medical Device Development

Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider.

Audit Trail Compliance And What To Look For In Mitigation Software

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

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WHITE PAPERS & CASE STUDIES

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    When Clean Is The Key To Precision

    Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink and precision rises, controlled environments are essential for quality, reliability, and regulatory success.

Why LSR Is A Leading Material For Optical Micro Molding

Liquid Silicone Rubber (LSR) is redefining optical micro molding with superior durability, design flexibility, and thermal stability—empowering next-generation optical components where traditional thermoplastics fall short.

How A Strategic Partnership Drove Micro Molding Success

In micro-manufacturing, supplier choice significantly determines success. Explore how one company transformed a struggling production program into a 150-million-part success through trust, scalability, and true strategic partnership.

Key Considerations For Selecting A Solenoid Valve In Health & Science Applications

Solenoid valves are vital in medical devices, enabling precise fluid and gas control. Explore customizable, high-reliability valves that optimize performance while conserving space, weight, and power.

How Sharp Packaging's Clinical Packaging Process Is 30% Faster

Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

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MANUFACTURING PRODUCTS & SERVICES

KittingandPackaging
Medical Device Assembly, Kitting and Packaging Services

SMC provides manufacturing and assembly services for full devices or subassemblies for finished devices. Our global facilities offer ISO 13485 systems for assembly as well as kitting and packaging services. SMC’s assembly services range from skilled human touch to fully automated assembly and testing equipment. Whether your program requires simple table-top fixtures or fully automated cells, our in-house automation team will assess your program and work with you to build a cost effective solution to meet your stringent requirements.

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Assembly Services

Complete outsourcing solution

B. Braun exclusively designs and manufactures products for the medical market. This single-minded focus on medical devices established our reputation for unrivaled quality. We’ve built advanced manufacturing facilities around the world, and our primary North American facility is no exception. It features state-of-the-art quality systems and ISO Class 8 clean rooms. With the flexibility to change from manual to semi-automated to fully automated assembly, they can produce both small- and large-scale volumes.

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ABOUT MEDICAL DEVICE MANUFACTURING

Medical device manufacturing includes all aspects of the fabrication of a medical device, from designing a manufacturing process to scale-up to ongoing process improvements. It also includes the sterilization and packaging of a device for shipment.

Throughout the manufacturing process, medical device makers strive to be faster and more efficient, but they also wish to be responsible corporate citizens. Thus, manufacturing demands constant insight into renewable resources, sustainable materials, equipment that is more energy efficient, and methods to reduce waste creation. Solutions to these issues can come in the form of improved processes, technological advances in machines or equipment components, or safer/more reliable materials. The same principles apply to the packaging process.

Such "LEAN" manufacturing is considered an industry best practice: eliminating any activity, process, or material that does not add value for which a customer will pay.

Still, while speed and cost-savings are vital to successful manufacturing, quality control is of the utmost importance — particularly as medical device market demands shift toward a more value-driven landscape. Packaging validation, proving to the FDA that a product is sterile when it ships, is the final step.

Many medical device manufacturers excel in the ideation, concept, and prototyping phases of product development and outsource the production of components or entire devices to contract manufacturers. This is as true of established original equipment manufacturers (OEMs) as it is for mid-sized companies and startups. Contract manufacturers vary in size and expertise, as well — some comprise small, precise operations specializing in particular materials or components, while others are massive cleanroom facilities equipped for large-scale production.

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