Dental Services
Many of our customers have reduced their time to market by partnering with us. We collaborate closely with their R&D teams, tackling tasks that would otherwise slow down a new product’s launch. This allows our clients to focus on their core business priorities while we handle the critical design, engineering, and development work.
Research and development
We use advanced simulation and modeling tools to optimize implant designs. To accelerate the development cycle, we provide access to specialized testing equipment and facilities and assign dedicated project managers to ensure seamless coordination and progress tracking.
Prototyping
Our prototyping service enables you to identify and address potential production challenges early in the development process, and include comprehensive Design for Manufacturability (DFM) analysis to streamline the production process.
We use rapid prototyping technologies including 3D printing and CNC machining to quickly iterate on designs, and conduct thorough testing on prototypes to validate performance, durability, and usability. We also incorporate feedback from end-users and stakeholders to refine the product design.
Testing
Develop and execute comprehensive test plans with us covering product performance, safety, and regulatory compliance, performing accelerated environmental and life testing to assess long-term durability and reliability.
Implementing statistical process control methods enables us to identify and mitigate sources of variability, and we establish robust quality control procedures during manufacturing. We also provide detailed test reports and documentation to support your regulatory submissions.
Regulatory affairs
Staying up to date with changes in global regulatory requirements for the dental implants industry enables us to advise you on the appropriate regulatory pathways for your products.
We can prepare and submit comprehensive regulatory documentation, including technical files and clinical evaluations. We liaise with regulatory authorities to address inquiries and facilitate approvals, and provide you with guidance on post-market surveillance and vigilance reporting.
Supply chain management
Leveraging our supply chain management service lets you focus on growing your business, while we manage the distribution of the final medical devices to the customer’s designated facilities, monitor inventory level (VMI), and facilitate re-ordering as needed to ensure a reliable supply chain.
Quality & validation
Our quality and validation support enables you to maintain a comprehensive quality management system that is aligned with industry standards, conducting rigorous process validation activities to ensure consistent product quality.
We are experts in implementing robust change management and deviation handling procedures to maintain process integrity and provide detailed documentation and traceability records to support regulatory compliance. Internal audits and corrective/preventive actions support continuous improvement of your quality system.
