Working with a specialized medical device contract manufacturing service provides any company with a solid, dependable partner to manage all aspects of the design through to production of simple to complex medical devices.
Finding the right partner for the job and to meet the specific requirements of the medical device should be an important first step in the process. Comparing different medical device contract manufacturers may take some time, but it is critical to find a company offering the services, expertise and the proven history of working in the medical device field.
Ability to Provide All Services
Not all medical device contract manufacturing companies offer all services. Some have specific areas of focus and may only complete some aspects of the prototype and production needs of the device.
There is an advantage in finding a contract manufacturer that is vertically integrated. These companies reduce the logistics in producing the part and also ensure greater quality control with fewer partners involved in the production.
Quality and Performance Issues
In most cases, a company offering medical device contract manufacturing will be ISO 9001 as well as ISO 19845 certified. They should also hold FDA compliance verification, an important consideration as it ensures fewer issues during the approval process.
It is also essential to complete due diligence in checking the performance record of the medical device manufacturing service. Companies with a history of producing equipment with defects or recalls should be avoided.
Professionalism and Communication
Make a commitment to meet personally, on location, to view the production facility as well as to talk to the engineering, design and production team. The best companies offer this type of meeting and provide clear, concise communication to any requests by current or potential customers.
Evasiveness, slow responses to communication or difficulty in getting information from the company are all warning signs of potential problems in the future.
