Orthopedic Services
Research and development
Developing your ideas
Our first step in the R&D process is to understand the project requirements and your goals in detail to ensure we share your view of successful outcomes.
We thoroughly analyze your guidelines so we can develop the best possible solutions. Based on this understanding, we will collaborate to create a detailed project plan that outlines the entire development process.
Design for Manufacturing
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.
Always thinking ahead.
With our focus on ready-to-use solutions, we look beyond designing products that are easy to manufacture and prioritize achieving your visions.
This means a detailed examination of every specific need from the beginning of our partnership so we can be sure to consider everything during product development.
Prototyping
Throughout the prototyping process, we combine advanced technologies and techniques to transform your concepts into physical prototypes.
We employ additive manufacturing with titanium or plastic, CNC machining, and other precision manufacturing techniques to provide our customers with high-quality prototypes to serve as the basis for further testing and evaluation.
Sterilization management
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.
Registration & technical documentation
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.
Validation and Registration
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 and registration support.
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.
Supply chain management
Leave the complexity to us.
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.
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.”
Instrument refurbishing
In addition to making instruments, we also excel in keeping them functional for the longest period. We do this by ensuring that every part, whether it remains in good condition or needs replacement after active use, is thoroughly inspected.
We aim to establish a systematic partnership to offer a robust maintenance program. This approach is vital for you and the end-consumer, ensuring that these high-performing products remain on the market for as long as possible.
Quality & validation
Quality management
We understand the importance of effective quality management to meet the high demands of the MedTech industry.
Our specialized team integrates quality management fully into the development and manufacturing process of your products, right through to final delivery, to ensure that your products meet the highest standards.
Regulatory expertise
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.
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
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.
