Surgical Medical Device Development Services
Go from concept to commercialization with Elos Medtech.
At Elos Medtech, we provide a wide range of pre-manufacturing, manufacturing and after-sales services. This comprehensive offering enables our partners to focus on what they do best; marketing and selling outstanding surgical products.
Research and Development
Embrace full collaboration with an experienced, forward-thinking partner.
With every new surgical device project, we begin by aligning with you on a shared vision of success.
This includes a thorough analysis of the project guidelines, a careful examination of every specific need from the beginning of our partnership, and a detailed plan for the entire development process.
By considering every single requirement from the beginning of the project, we set our partnership with you up for success.
Prototyping
We apply a wide range of technologies to transform your ideas into physical prototypes, including additive manufacturing with titanium or plastic, CNC machining, and other precision manufacturing techniques.
From advanced additive manufacturing (titanium and/or plastic), CNC machining and other precision manufacturing techniques to provide you with high-quality prototypes that meet your requirements. These prototypes serve as the basis for further testing and evaluation.
Because better prototypes equal better products.
Registration and Technical Documentation
We stand by your side throughout the certification process, supporting you in communication with the Notified Body and authorities. We can participate in audits and help identify and address any deviations to ensure a smooth certification process.
Given our specialized focus on delivering ready-to-use solutions, we are well-equipped to ensure that the medical devices coming out of our facilities meet the highest standards of safety and cleanliness.
As part of our sterilization management service, we work with you to assess your particular needs and support you in choosing the best sterilization methods. We work with trusted and qualified partners to perform sterilization efficiently and compliantly.
Design for Manufacturing (DfM)
Our “Design for Manufacturing” service focuses on optimizing the design of medical devices during the development phase. This is to ensure efficient and cost-effective manufacturing of your future medical devices.
By considering manufacturing aspects such as material selection, production methods, and assembly processes, we enable smooth and high-quality manufacturing for your products while meeting regulatory requirements.
Mold and Tool Manufacturing
As we offer our customers a wide range of possibilities, we ensure that we build and maintain the expertise to develop and manufacture medical devices and the ability to create the tools to do so. By working with us, our customers gain the advantage of partnering with a company that has *nearly fully integrated manufacturing and services capabilities.
*Albert, Einstein. “Once you stop learning, you start dying.”
Validation and Registration Support
We support you in complying with the applicable regulatory requirements and standards for medical device manufacturing.
Our experts are well-versed in regulatory regulations and can assist you in obtaining the necessary certifications and conformity assessments to ensure the smooth market entry of your products.
Regulatory analysis and consultation
Our service includes thoroughly analysing your product design and concept to ensure it complies with regulatory requirements.
We offer regulatory consultations during the development phase to maximize your chances of certification success. Our experts support you with advice and recommendations on potential improvements to meet requirements and successfully complete certification.
Sterile Packaging
Innovation in packaging services
We work closely with our customers to craft packaging solutions that complement your product impeccably, customizing every aspect, from material selection to incorporating your branding.
With two distinct packaging options to choose from, faster or tailor-made, giving you a choice between reduced time-to-market or maximal customization.
Time and cost savings
By outsourcing their packaging process to us, our customers can redirect their focus towards their core areas of expertise. We provide cost-effective solutions that ensure efficiency and safety throughout the process. Our approach is designed to offer swift turnaround times without compromising on quality, allowing you to meet your objectives with confidence and ease.
Faster with pre-validated packaging
Our pre-validated packaging saves you time by streamlining the validation process, cutting it down by up to 15 months and extending shelf life to 7 years. Additionally, it allows you to enjoy cost savings with minimal to no investments required for tooling.
Quality and Validation
Every medical device must undergo a series of validations. Even before manufacturing begins, an experienced partner is needed to ensure the quickest possible market entry.
Our quality department supports you throughout the validation process, FDA/CE documentation, and registration of your medical device.
We offer:
- Mechanical testing
- Packaging validation
- Sterilization validation
- FDA/CE documentation
- Registration support
Validation support
In the area of validation, we support you in creating a product-specific validation program as well as in organizing and conducting the validation itself.
Medical device validations are carried out in-house or in collaboration with accredited partners.
Benefit from the extensive experience of our experts, who can assist you with:
- Cleaning validation
- Packaging validation
- Sterilization validation
- Transport and environmental simulations
Supply Chain Management
We can handle every aspect of your supply chain and leave you carefree to focus on what you do best – growing your business.
From procurement to distribution, we ensure seamless operations, optimal inventory levels, and risk mitigation, all while providing transparent communication and proactive problem-solving. With us by your side, you can enjoy peace of mind knowing that your supply chain is in expert hands, allowing you to stay focused on your core objectives and drive success.