Life Science Services
Research and development
Developing your ideas
The first step in our R&D process for life science manufacturers is to understand the project requirements and 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 product development process.
Design for Manufacturing
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.
Our Design for Manufacturing services ensure the designs for your devices and components are tailored from the start to make the manufacturing process as efficient and cost-effective as possible.
Always thinking ahead.
With our focus on ready-to-use solutions, we go beyond just designing your products to be easy to manufacture. This means detailed examination of every one of your requirements from the beginning of our partnership, so we can be sure to consider everything during product development.
Ensuring compliance and reliability
We take several steps to prepare your products for regulatory compliance and total effectiveness in their intended applications.
Our design control processes are provided in accordance with ISO 13485. We can offer our own proprietary testing equipment and access to certified medical labs for mechanical testing. We also have access to dry and CAD labs for product development and design optimization and universities to support clinical studies.
Prototyping
We leverage all necessary technologies and techniques to transform your concepts into representative physical prototypes. We have specific expertise with additive manufacturing in high-quality class III Ti6Al4V and SLA Technology.
We supplement this with CNC machining and other precision manufacturing techniques as appropriate to provide our customers with high-quality prototypes to serve as the basis for further testing and evaluation.
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 specific needs and select the most appropriate sterilization methods. Partnering with trusted and qualified experts, we guarantee efficient and compliant sterilization of your medical devices.
Registration & technical documentation
Regulatory analysis and consultation
Our registration and technical documentation service begins with thoroughly analysing your product concept to ensure regulatory compliance.
During the development phase, we offer regulatory consultations to make a head start on certification. Our experts advise and recommend potential improvements, helping you meet all requirements and achieve successful certification.
Validation and registration
Every medical device must undergo a series of validations before manufacturing begins. Our quality department supports you through the entire validation process, including mechanical testing, packaging validation, and sterilization validation.
We also assist with FDA/CE documentation and registration to ensure the quickest possible market entry for your device.
An expert partner
Our experienced team has extensive knowledge of regulatory requirements and standards in the medical device industry. We are well-versed in CE and FDA certification guidelines and are ready to assist you in meeting all necessary regulatory requirements.
Throughout the certification process, we support you in communicating with Notified Bodies and authorities, participating in audits, and addressing any deviations to ensure a smooth certification journey.
Supply chain management
Leave the complexity to us.
Our full supply chain management service helps you focus on what you do best. We manage every aspect of your supply chain, including logistics and customs, so you can focus on growing your business.
We ensure seamless operations, optimal inventory levels, and risk mitigation from procurement to distribution. Throughout this process, we communicate with you and problem-solve proactively to ensure that your supply chain runs smoothly. 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
We provide our customers with a broad range of possibilities, ensuring not only the expertise to develop and manufacture medical devices but also the capability to create the necessary tools for these processes.
Partnering with us means gaining the advantage of our nearly* fully integrated manufacturing and service capabilities, offering a seamless and efficient experience.
*Albert, Einstein. “Once you stop learning, you start dying.”
Instrument refurbishing
In addition to making instruments, we excel at keeping them functional for the longest period. We do this by thoroughly inspecting every part, whether it remains in good condition or needs replacement after active use.
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 critical need for effective quality management in the MedTech industry. Our specialized team integrates quality management throughout the development and manufacturing process, ensuring your products meet the highest standards from start to finish.
Regulatory expertise
We help you comply with regulatory requirements and standards for medical device manufacturing. Our experts are knowledgeable in regulations and can assist you in obtaining the necessary certifications and conformity assessments for smooth market entry.
Validation support
We assist in creating and executing product-specific validation programs, either in-house or with accredited partners. Our experts bring extensive experience in:
- Cleaning validation
- Packaging validation
- Sterilization validation
- Transport and environmental simulations
Our pre-validated sterile packaging solutions can save you up to 15 months by simplifying this part of the process.
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.
There are two distinct packaging options, 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 while also extending shelf life to 7 years. Additionally, it allows you to enjoy cost savings with minimal to no investments required for tooling.
