The cost of moving a medical device from a concept through to approval and then into production is mounting every year. In addition, the time to get new devices approved also tends to increase, particularly if there is an issue with validation, documentation or meeting specific requirements.
To help alleviate these issues, pharmaceutical and medical device companies are turning to medical device contract manufacturing services to complete specialized aspects of production. This is very effective to make production more cost-effective, to increase quality control and to complete very precise elements of the production by specialized companies.
When hiring a company for medical device contract manufacturing, it’s important to think of the task as bringing a partner in the project. These companies have to work with the supply chain, to specifications and within all regulations and requirements for production.
Make sure the company hired for medical device contract manufacturing has a firm understanding of the documentation that they will be required to produce and maintain will be a very important factor.
Don’t assume that a company that markets themselves as a medical device contract manufacturer has the experience and expertise needed for your class of medical device. Verify the company has extensive work in production before determining if they are the best match for the job.
Understand Their Internal Quality Control
Developing a prototype or an initially small volume production is relatively easy to maintain quality control. However, with full large-scale production, an inexperienced company may push orders through the system quickly to meet deadlines and requirements of their customers.
Always make sure the contractor is ISO 9001 registered as well as ISO 13485 certified. Take the time to talk to the company specifically about quality control and be confident that the policies the company has in place will be maintained from the first component produced through to the last.
Be the first to like.