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 50 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.
Sustainability support
We are dedicated to make a positive impact through sustainable practices. Our well-defined Environmental Social Governance (ESG) strategy guides our efforts in reducing our carbon footprint and supporting the U.N. Sustainable Development Goals.
Recognized with an EcoVadis Silver Medal, we continually innovate to create eco-friendly solutions that benefit both patients and the planet.
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.
Digital health
SHL Medical is pioneering new digital healthcare pathways that lead to the development of connected, patient-empowered, and data-rich platforms. Through our Innovation Partnership program, we leverage our expertise in autoinjector design and development to support pharma and biotech companies map their therapies with connected devices that can fit into any digital ecosystem.
Backed by our mature device infrastructure, SHL is ideally positioned to lead the way for self-injection solutions to become connected and integrated in support of pharma’s digital transformation journey.
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Connected device development
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Device-to-cloud digital ecosystem integration
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Innovation Partnership – Every injection Counts™ program
Get in touch
Got a question? We have got the answer! Reach out for questions, ideas, partnerships, or anything else you want us to know about.
Email us
We usually respond within 24 hours on working days.
[email protected]
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