Medical device OEMs can benefit from working with EMS
partners with the technology expertise to start up new manufacturing lines
quickly, perform final testing, and ensure that products meet appropriate
standards. How to choose a proper EMS partners for you? Below is some
tips
a. Technology expertise
When introducing a new product, the OEM should also consider
a contract manufacturing company that maintains an engineering support staff.
An experienced supplier’s engineering team can implement small changes to the
design of a product or the manufacturing process, helping to reduce costs
without erecting regulatory hurdles.
b. quality systems
It is important for EMS providers to have experience
performing final device testing, since testing can be technically challenging
and the consequences significant if it is not performed correctly. Testing
experience could include burn-in testing for electrosurgery devices
or wet QC tests for IVD instruments
c. Certificates
Full-service EMS suppliers, which provide engineering as well
as manufacturing of finished products, should be aware of the IEC 60601-1 third-edition testing
standard. Upon bringing this change to the medical device OEM’s attention, the
contract manufacturer should be able to help the OEM to understand the
third-edition documentation and testing required to receive a CE mark. For
laboratory instruments, IEC 61010-1
third edition has been required.
Are there any other factors that you can think about for choosing
a EMS partner?
