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Quality Management System for Medical Device Manufacturing
Star Rapid is proud to announce that we have completed the certification process for ISO 13485.
What is ISO 13485:2016?
ISO 13485 is a set of standards that define and control a company’s quality management system, specifically regarding the manufacturing of medical devices and other health-related products.
This standard is used as a precursor to the submission of products for regulatory approval to government bodies such as the FDA in the United States or the European Medicines Agency (EMA).
Although not in itself a specific license to make any medical device, it is a clear demonstration of a supplier’s accountability and conformance to industry best practices when making components that are essential for safeguarding human health.
To attain this prestigious certification, Star Rapid was audited by the independent firm TÜV Rhineland according to several important criteria.
1. Risk Management
All processing steps are carefully analyzed to determine what risk they might pose to the quality of the finished product.
2. Clarification of Management Responsibilities
Everyone in the organization knows their roles and responsibilities and can report effectively and quickly.
3. Enhanced Training
A training system is in place to continuously update the skills of all key manufacturing personnel involved in quality.
4. Facility Improvements
The facility has been improved to provide for better material control, cleanliness, part tracking and production efficiency.
5. Design and Development
Procedures have been streamlined and rationalized to improve the design and development process for certain product
categories.
6. Control of Suppliers
For raw materials and other sub-contracted supplies, traceability and accountability is more robust for every link in the
value chain.
What does this mean for our clients?
Star Rapid is prepared to support you when it’s time to bring your medical devices to market fast. With our comprehensive range of in-house services we can help you create rapid prototypes, tools and production parts that will help you to deliver solutions for your most demanding medical applications.
The ISO 13485 certification is yet another demonstration of our commitment to total quality management. We will apply this level of professional service not only for medical products but also to any project that requires the industry’s finest attention to detail, accountability and rapid turnaround. Contact us today to learn how we can work with you.
