Medical Device Manufacturing

INDUSTRY PERSPECTIVES

Making The Call On Pre-Validated Packaging

The idea of pre-validated packaging sounds really good. Using packaging that has already undergone extensive testing seems fast, easy, and less expensive. Is it truly the answer? It depends.

Implementing And Optimizing Your eQMS

This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

CSV Assumes The AI System Sits Still — It Doesn't.

The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

Selecting A Prefillable Syringe System With Confidence

Prefilled syringe selection can stall drug development for months. This system integrates barrel, plunger, and needle shield from a single supplier, reducing complexity for emerging biotech.

More Perspectives On Medical Device Manufacturing

WHITE PAPERS & CASE STUDIES

Advancing Biopsy Device Performance Through Precision Overmolding And Assembly

Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

POC Diagnostics: 4 Considerations For Bridging The Gap From Development To Commercialization

Scaling point-of-care diagnostics requires integrating microfluidics, chemistry, and automated assembly early in development. Aligning these pillars reduces risk and speeds time-to-market.

When Plastic Meets Metal At The Micron Level

Micro insert molding enables smaller, more integrated medical devices—but reliable polymer-metal interfaces require precise insert handling, material selection, positional control, and validation.

Manufacturing Readiness: Why Compliance Is Won Or Lost On The Floor

Achieve continuous regulatory readiness by embedding ALCOA++ compliance directly into manufacturing workflows to eliminate paper-based documentation risks.

More White Papers & Case Studies

MANUFACTURING PRODUCTS & SERVICES

MasterControl QMS
Quality Management System (QMS) For Drug Manufacturing

The #1 QMS In Life Sciences Puts You in Complete Control

MasterControl Quality Excellence is trusted by 1,100+ customers — from startups to global enterprises — to bring quality products to market faster.

It's time to close the loop on quality—from quality event management to document management and training—and see how MasterControl quality management system can transform your business today.

MasterControl MES
Modern MES Software For Drug Manufacturing

Eliminate errors and accelerate production with MasterControl MES.

MasterControl Manufacturing Excellence is a modern manufacturing execution system (MES) that has helped hundreds of manufacturers eliminate millions of errors and deliver products to the market 70% faster.

It’s time to modernize your manufacturing operations – from digital work instructions and production records (EBR/eDHR) to electronic logbooks and equipment tracking – and see how MasterControl Manufacturing Excellence software can help you run faster, leaner, and smarter.

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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.

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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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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