When it comes to choosing orthopedic implant manufacturers, there are some obvious issues that any company will want to compare and assess. Many of the design teams focus on the most evidence factors to compare including price, capacity and experience.
Of course, the actual factors for comparison tend to fall into various subcategories, so there are more than just these three. However, many companies do tend to focus in on the price and the experience to the greatest degree with the capacity to produce in-house as the third.
While this is not a bad approach, there is one other essential consideration for comparing orthopedic implant manufacturers. This has to do with the method of quality control used in the production and how that has the potential to impact your product.
ISO 9001:2008 and ISO 13485
The Best orthopedic implant manufacturers will have both ISO 9001:2008 and ISO 13485 certification. The first standard is designed to focus the company on meeting the standards for implementing a quality management system throughout the facility and production.
The second certification, ISO 13485, is specifically designed as an international quality management system for producing all types of medical devices. This includes training and demonstration by the company about the regulatory requirements for the production of medical devices, including those used in orthopedic procedures.
When orthopedic implant manufacturers have this certification, they will understand the importance of traceability for all parts and components used in the device. They will also be familiar with the validation process required for any medical implants and devices and they will understand design control that is required for production.
Price, experience and capacity, while often the first comparisons, really are meaningless unless the manufacturer knows and works to both quality management standards as well as those specific to medical device development and production.
