One-Stop Shop
Our comprehensive range of services allows you to focus on your core business while leveraging our infrastructure, polymers expertise, and advanced manufacturing capabilities. We cover every stage of product development, regulatory support, and the high-precision manufacturing of polymer components for medical device, diagnostics, and life science applications.
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.
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 a wide range of manufacturing techniques to provide our customers with high-quality prototypes to serve as the basis for further testing and evaluation.
Certification 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.
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.
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.
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.
Automated Production Set-Up
Our automated cleanroom production setup ensures high-efficiency, contamination-free manufacturing for medical polymer components, supporting both low and high-volume production with consistent quality and regulatory compliance.
By leveraging advanced robotics, process automation, and ISO-certified cleanroom environments, we minimize human intervention, reduce costs, and enhance precision for single-use devices, diagnostic consumables, and implantable components.
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.
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
Sterilization Management
In line with our unique focus on delivering ready-to-use solutions, we are experts in ensuring that your medical devices meet the highest safety and cleanliness standards.
As part of our sterilization management service, we collaborate with you to assess your needs and select the most appropriate sterilization methods.
Partnering with trusted and qualified experts, we guarantee efficient and compliant sterilization of your medical devices.