Meet the needs of your medical device supply chain with Unitek Technical Services. We provide a range of quality assurance solutions, including medical equipment source inspections and process monitoring, to help optimize compliance, reduce production times and manage costs effectively. We can help you stay at the cutting edge of medical technology, producing the in-demand products that patients need.
Get Help With Compliance and On-Time Delivery
Our services support compliance with relevant regulations such as those set by:
- The U.S. Food and Drug Administration (FDA)
- ISO 13485 from the International Organization for Standardization (ISO)
- China National Medical Products Administration (NMPA)
- The European Union Medical Device Regulation (EU MDR)
Besides supporting compliance, we can introduce quality assurance earlier into your production cycles through services such as medical supply chain risk assessment, which may help prevent nonconformance and product recalls. Our in-depth services help with initial supplier qualification and ongoing monitoring, which identify areas for improvement early in the process, before devices go to customers.
Our services keep your supply chain running efficiently while maintaining effective cost control. We can help you optimize your resources to free up capital for research and development, clinical trials or other critical tasks. Our services can also help you bring new products to market faster and respond to ever-changing public health needs.
Our Proven Solutions for Medical Device Quality Assurance
We provide a wide range of quality assurance services, including:
- Supplier development: Suppliers at every stage in your supply chain must deliver conforming components for you to create effective medical devices. We offer medical device supplier development programs, such as process monitoring and root cause analysis, to assess suppliers and work toward improvements.
- Audits and surveys: Given the number of regulations in the medical device industry, you will often face audits and surveys from regulators and customers. We can help review quality management systems and benchmark your processes against relevant regulations with medical device supplier audits.
- Product verification: Verify your products to ensure compliance with specifications. Our services cover various aspects of medical equipment product verification, including test witnessing and pre-cap inspections of hybrid microelectronic devices, such as pacemakers or neurostimulators.
- Technical support: Many tasks occur behind the scenes, from extensive documentation and reporting to communication. We offer technical support, such as serving as engineering liaisons or completing supplier scorecards to review quality and delivery.
- Supply chain management: Our expertise covers complex, global, highly regulated supply chains in the medical industry. We can help identify vulnerabilities, evaluate suppliers and keep production for lifesaving products on schedule.
How We Stand Out
In the medical industry, you need more than a partner in supply chain management. You also require in-depth, industry-specific expertise and dedicated support. Unitek Technical Services stands out for the following reasons.
Deep Expertise
Many of our Technical Specialists have over 20 years of experience. They also hold specialized certifications and subject matter expertise for the particular industries they serve. As a company, we are backed by Kiwa, a global leader in testing, inspection and certification. This strong foundation gives us the resources and knowledge to serve you.
Dedicated Support
We get to know each client individually, so we can understand your operations and the areas where you most need support. We provide you with a dedicated project manager who can answer your questions and assist you throughout various management processes.
Technology Utilization
We establish a customer intranet through Launchpad, where you can schedule inspections and view the results. This secure online portal lets you check the status of parts and acceptance processes anytime.
Secure the Future of Your Medical Supply Chain
Unitek Technical Services offers specialized supply chain management services for the medical industry. Contact us to learn more about what we do or to schedule an inspection, audit or other service. We’ll learn your unique needs and tailor our services accordingly for high-quality support.
