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Life Science Outsourcing’s veteran team of experts shares cutting-edge resources, regulatory insights, and partner-ready solutions.
Technical Terms Glossary
Decoding the language of medical device manufacturing
Meeting the stringent new CE mark recertification MDR requirements will take time, planning, and expertise. This is what you need to know to get started.
Medical Device Manufacturing

What do Medical Device OEMs Need to Know for MDR CE Mark Recertification in Europe?

The medical device industry is only a few years away from the MDD becoming the MDR for CE mark recertification in Europe. On average, it takes 18 months to recertify medical devices – meaning that slower-to-adopt companies may fall behind and risk losing certification altogether.
Medical Device Manufacturing

3 Requirements for Reliable Manufacturing Supply Chain Continuity

Medical device companies have a real challenge when managing diverse supply chain demands, especially if they utilize multiple resources to achieve disparate processes. And it’s no surprise that difficulties will continue to arise as we move into 2024 in the form of new requirements, resource access limitations, a lack of in-house expertise, and disconnected communication channels.
024 Medical Device Supply Chain Strategies
Medical Device Manufacturing

2024 Medical Device Supply Chain Strategies Require These Pivotal Approaches to Succeed

Medical device OEMs must anchor their supply chains with agility and foresight to successfully navigate 2024 challenges. The key? Embrace the trifecta of change: advanced sterilization methods, flexible supply models, and the race for time efficiency. OEMs who master these elements will not only endure but lead the charge in a new era of medical innovation.
LSO offers medical device assembly for combination products.
Medical Device Manufacturing

Exploring Combination Products Medical Device Assembly: Certifications Requirements and Outsourcing Solutions

Recent data reveals that up to 30% of FDA submissions now focus on combination products. In our latest article, we explore their definition and their diverse categories, including the fusion of drugs, devices, and biological products. The allure of combination products is based in their myriad benefits: From localized treatment and streamlined processes to minimized contamination risks and precise dosage control, they are elevating patient treatment and care.
Medical device product scalability isn’t just about making more product – it’s about long-term capabilities, resources, and infrastructure. Learn more.
Medical Device Manufacturing

How Can Medical Device Companies Achieve Sustainable Scalability for Long-Term Growth?

Rapid growth can strain supply chains, cause production bottlenecks, and increase lead times. That’s why scalability isn’t just about making more units. How can companies ensure they’re ready for future growth scalability? By building a rock-solid infrastructure with a reliable contact manufacturing partner.
Medical device startups need clean rooms and equipment to fast-track new products to market. The right contract manufacturing partner can help
Medical Device Manufacturing

Using Contract Manufacturer Facilities and In-House Services Expedites Medtech Time to Market and Reduces Risk

Contract manufacturers can help startups expedite time to market with versatile facilities and in-house services that can save you from these pitfalls and give your startup the flexibility it needs to thrive. They can guide you from R&D to commercialization and fast-track your product journey success. Look for partners with labs, testing equipment, and clean rooms able to meet your short- and long-term goals.
Medical Device Manufacturing

MedTech Startups Benefit from Comprehensive Incubator Services for Long-Term Market Success

Medical device startups face many challenges to get their product to market – and they often struggle with the multitude of strategic steps and regulations necessary for long-term success. Our own CEO John Nino recently sat down with MPO magazine Editor-in-Chief Sean Fenske to discuss how such startups can benefit from more effective facility utilization to meet their diversified needs.
Medical Device Manufacturing

Medical Device Manufacturing Must Evolve to Keep Pace With the Times

Recent industry changes, shortages of materials and sustainability priorities have transformed medical device manufacturing methods. It’s time to reassess packaging and sterilization processes, adopt novel solutions and identify new efficiencies. Learn how your organization can evolve to stay current.