Medical Device Manufacturing

INDUSTRY PERSPECTIVES

How AI Is A Game-Changer For Auditing Compliance And Efficiency

In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

Struggling With GxP Systems? There's A DAP For That

A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

Risk Management Planning: Be Prepared When Disaster Strikes

Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.

The Future Of Medical Device Labeling Is Here

Medical device labels that lack information or contain inaccurate information may lead to product recalls or delays in product release. Generative AI offers a solution to streamline the labeling development process. 

WHITE PAPERS & CASE STUDIES

Success In Times Of Crisis: A Journey From Concept To Market In 8 Months

Medbio ensures seamless tool transfers for medical device manufacturing by assessing tools, implementing improvements, and minimizing downtime to maintain quality, efficiency, and regulatory compliance.

Meeting Annex 1: A Proactive Approach To Regulatory Compliance

It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

Future-Proofing Micro Molding: Why Choosing The Right Partner Secures Long-Term Success

Micro molding is essential for high-precision industries. Choosing the right partner ensures scalability, reliability, and innovation, minimizing risks and disruptions while future-proofing supply chains for sustained success.

Ultrathin-Wall Heat Shrink Tubing Ideal Solution For Microablation Device

A virtual start-up partnered with Nordson MEDICAL for complete design, development, and manufacturing of a catheter-based device for TAVR patients, leading to CE mark and acquisition.

MANUFACTURING PRODUCTS & 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.

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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