Device support services
We offer a wide range of support services to ensure your device’s success at every stage.
From development to commercialization, our solutions streamline your journey, bringing products to market faster.
About our support services
Our device support services and capabilities are integral to the success of every device project. We integrate quality, regulatory, and supply chain expertise at each stage of the product lifecycle to meet clinical, commercial, and aftermarket needs.
Our approach to device development fully integrates these essential elements, optimizing timelines and reducing costs.
By staying ahead of market trends, we deliver sustainable benefits that enhance value across the entire development process.
Project management
Our global team of project and program managers leads every project using agile methodologies to meet the growing demands of the healthcare industry. We focus on seamless execution and risk reduction, ensuring that each project runs smoothly from start to finish.
With a proven track record of commercially launched combination products, we streamline communication and collaboration to keep your project on track.
Regulatory affairs and complicance
A medtech company’s regulatory affairs (RA) competency is paramount to its products’ pre- and post-approval success. SHL Medical’s Regulatory Centers of Excellence (CoE) service model, adopted at each of our offices worldwide, ensures applicable regulatory intelligence across our global operations. As the only medical device company that has supported over 50 combination product launches across various markets, therapy areas, and end user portfolios, our decades of groundwork on regulatory support for customers is unparalleled.
- Compliance with medical device CGMP
- Global RA support through Regional Regulatory Centers of Excellence service model
- Unparalleled support for over 60 combination products
Quality systems
Quality is at the core of our operations. We adhere to the strictest industry standards, including ISO 13485 and FDA 21 CFR 820, ensuring that our processes and products meet global compliance requirements.
From in-process testing to post-market surveillance, our dedicated QA/QC specialists work closely on each project to deliver the highest level of safety and reliability.
Alliances
To further strengthen capabilities in vertically integrated solutions, we are building a partnership ecosystem.
We believe that maximizing value for our customers requires connections within the drug delivery ecosystem, so that we can provide expert advice, recommendations, and options for our customers along the value chain.
That’s why we have initiated the Alliance Management program to build strong partnerships along the pharma and drug delivery value chain. Our partners include primary container providers, CMOs/CDMOs, and other service providers and suppliers.
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IP support
Intellectual property (IP) is an intrinsic concern when developing any product with a customer. We offer customers a range of product options, designs, and configurations backed by SHL’s extensive intellectual property experience, portfolios, and know how. The composite of these provides our customers the opportunity to best maximize their combination product portfolios while relying on SHL’s broad intellectual property capital to ensure that they are protected in the market.
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IP FTO built into customer product development
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Flexible approach to IP management and protection
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Customized IP solutions for every project
Data support
We are advancing data support services to drive smarter decision-making for our partners. Our team of data engineers and scientists is building a robust infrastructure for data-sharing and analytics.
We aim to offer solutions that range from one-way data insights to real-time and predictive analysis, customized to meet your specific needs and business goals.
Get in touch
Covering the full drug delivery value chain, we provide peace of mind by offering end-to-end services.
Services
Learn more about the integrated services we offer.
Products
Learn more about our products
Partnerships
We are building a partnership network in various areas to enhance offerings for customers along the entire device value chain.
Call us
Mon-Fri from 8:00AM-5:00PM (GMT+2)
+41 41 368 00 00
Visit us
You can find our office HQ at
Gubelstrasse 22
6300 Zug, Switzerland